SHANGHAI CAREERS

 

J. Edgar and Associates Inc. has been a leader in Technical Search since 1992. If you are currently in the market for a new employment  opportunity,  we  invite you to view the current opportunities below.

Hot new positions...Principal Biostatistician/Site Leader...Principal Programmer/Site Leader...Principal Biostatistician...Sr. Biostatistician...Sr. Principal Programmer...Jr.- Sr. Biostatistician...Sr. Statistical Programmer...Jr. Statistical Programmer...


PRINCIPAL BIOSTATISTICIAN AND SITE LEADER DUAL ROLE TO RMB 850,000 PLUS 10% BONUS, PUDONG ZHANGJIANG NEW DISTRICT, CHINA TO START ASAP IN THE NEW YEAR 2019

Our client has opened a third international location in Shanghai and we are searching for several senior talented Leaders who will be accountable for developing, applying and/or providing expertise in clinical trial statistical and programming methods and techniques to effectively manage and complete statistical and programming projects, and to support the company’s mission, strategies, customers and priorities. In addition to the technical accountabilities, this position assumes project management responsibilities in directing and managing statistical and programming team activities for clinical trials from the development of study protocols to the completion of study reports. To drive the expansion of the Shanghai site, we are seeking a customer-focused, deeply experienced, and hands-on Principal Biostatistician to help to lead our clients teams as Site Leader for their Shanghai, China location. The incumbent in this unique role will receive highly competitive compensation and benefits. A highly driven, team-oriented, and quality-focused individual will have the potential to further advance to technical or business leadership positions. May represent division and the company, participate in business development and customer relationship management activities, and provide leadership in executing divisional and corporate plans.

Qualifications and Experience:

1. Provide leadership/expertise in day to day statistical and programming team operations and in resolving complex problems for assigned projects, or as a consultant to others. 2. Act as Lead Biostatistician/Teammate Biostatistician to interact with clinical trial sponsor companies, and oversee projects for a sponsor company and/or for given therapeutic areas. 3. Lead assigned projects by applying project management skills, statistical and programming techniques to deliver quality and timely deliverables. 4. Plan, develop and monitor timelines for statistical and programming activities in accordance with medical/clinical activities for assigned projects. Jointly with immediate management, assess statistical and programming resource needs and manage the assigned resources to the projects. 5. Write Statistical Analysis Plans (SAPs) for assigned projects. Perform review on the SAPs written by others. 6. Perform review of clinical trial documents, including but not limited to the following: study concept sheet, protocol synopsis, protocols and amendments, statistical and programming documents generated by others, and clinical study reports or publications.7. Develop or perform review of statistical programming technical specifications, which include but not limited to the following: clinical trial data handling rules, statistical derivations/algorithms, SDTM and ADaM dataset specifications, and statistical testing/modeling approaches. 8. Perform quality control (QC) activities on statistical datasets such as SDTM and ADaM datasets. Perform quality control (QC) activities on statistical analysis results or data displays such as statistical summary tables, listings, and graphs (TLGs). Provide statistical and programming input into clinical trial Case Report Forms (CRF) design for assigned projects, and may provide input to the database design data flow, variable naming conventions and data structure, etc. when required. 9. Write statistical and results sections of the Clinical Study Report, or perform QC review of the CSR. 10. Participate and contribute to the training, mentoring, and development of new Biostatisticians or Statistical Programmers. 11. Contribute to organization development and growth by participating in the interview and evaluation process for job applicants.

Qualifications and Experience: 

• A Ph.D. degree in statistical science plus at least five years of relevant experience, which includes three years in a senior biostatistics role with experience doing statistical analysis.

• Proficient with SAS, statistical modeling, submission standards (CDISC), writing SAPs, and writing statistical components of the clinical study reports for clinical trials.

• A College English Test (CET) 6 certificate is highly preferred.  OR

A Master’s degree in Statistics, Biostatistics, Bioinformatics, Computer Sciences, Mathematics, or other relevant fields is required with at least 10 years of relevant industry experience using SAS in clinical trial analysis and reporting. • A College English Test (CET) 6 certificate is highly preferred. • In-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis. • Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented to regulatory agencies. • Knowledge of clinical trial regulatory, ICH GCP, and CDISC requirements. • Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data/results with documentation to regulatory agencies.• Strong leadership skills, commitment and drive to achieve goals.

If you are interested in confidentially exploring this career opportunity, kindly send your resume to me directly at: jedgar@sympatico.ca,   Cris Murray 416 225-6386 VP Recruitment and Training

I will call or email you the name of our client once you submit your resume so you can determine if you would like to be represented to our client for an interview.


PRINCIPAL PROGRAMMER AND SITE LEADER DUAL ROLE TO RMB 850,000 PLUS 10% BONUS COMMENCING AFTER 6 MONTHS SERVICE, BASED IN SHANGHAI (PUDONG ZHANGJIANG NEW DISTRICT, CHINA TO START ASAP IN THE NEW YEAR 2019

Our client has opened a third international location in Shanghai and we are searching for several senior talented Leaders who will be accountable for developing, applying and/or providing expertise in clinical trial statistical and programming methods and techniques to effectively manage and complete statistical and programming projects, and to support the company’s mission, strategies, customers and priorities. In addition to the technical accountabilities, this position assumes project management responsibilities in directing and managing statistical and programming team activities for clinical trials from the development of study protocols to the completion of study reports. To drive the expansion of the Shanghai site, we are seeking a customer-focused, deeply experienced, and hands-on Statistical Programmer or Biostatistician to help to lead our clients teams as Site Leader for their Shanghai, China location. 

The incumbent in this unique role will receive highly competitive compensation and benefits. A highly driven, team-oriented, and quality-focused individual will have the potential to further advance to technical or business leadership positions. 

  May represent division and the company, participate in business development and customer relationship management activities, and provide leadership in executing divisional and corporate plans.

Qualifications and Experience:

1. Manage the Shanghai office operation by instilling and promoting corporate culture and values including adherence to the Code of Conduct; planning and organizing site specific events and activities; working with the functional group leaders in North America to ensure a smooth Shanghai office operation supporting quality and timely services to clients.

2. Oversee day-to-day operational effectiveness and efficiency of the Shanghai office, including, but not limited to: Appraising line management and upper management of site-specific needs and achievements. Appraising the central Information Technology Team in Canada of any local system connectivity or computing performance needs.  Liaising with local facilities management regarding office maintenance and procurement needs.  Assisting headquarter management function on certain local business activities for the Shanghai office, such as interacting with local clients, business partners, and vendors for office management needs, etc. 3. Support of staff recruitment, hiring, on-boarding, and ongoing mentoring of new Shanghai employees. 4. Represent corporate leadership during Shanghai site visits by clients, regulatory authorities, or auditors. Lead deliverable tasks in a timely, accurate, and efficient manner to ensure quality and productivity. These tasks may include, but are not limited, to the following: 1. Lead study teams by participating in resource planning and managing timelines and deliverables. This includes managing programming assignments for project team members and following up on task status to ensure deliverables are completed on time and with quality. 2. Prepare SDTM data mapping specifications, ADaM dataset specifications, data reviewer’s guides and define.xml documents. Perform QC review of these documents prepared by others. 3. Program SDTM and ADaM datasets according to approved dataset specifications. 4. Generate complete and accurate statistical tables, listings, and graphs (TLGs) in accordance with Statistical Analysis Plan (SAP) and well-defined formats. 5. Document data and programming information in accordance with SOPs and/or clinical trial sponsor’s specific requirements. 6. Perform independent SAS programming validation of datasets and TLGs programmed by others. 7. Perform 3rd level QC review and programmatic checks on programming deliverables before releasing them to clients. 8. Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming. 9. Archive clinical trial data (raw data, SDTM, and ADaM datasets) and programming documentation in accordance with SOPs and/or clinical trial sponsor’s specific requirements. 10. Actively contribute to the continuous improvement of clinical data standards, conventions and statistical programming SOPs. 11. Design and implement SAS macros to enable standardization and efficiency in statistical programming.

Qualifications and Experience:

A Master’s degree in Statistics, Biostatistics, Bioinformatics, Computer Sciences, Mathematics, or other relevant fields is required with at least 12 years of relevant industry experience using SAS in clinical trial analysis and reporting  OR A Ph.D. degree or equivalent in statistical science, mathematical analysis or related plus 10 years of relevant experience leading a small team of 5-6 direct reports.

• A College English Test (CET) 6 certificate is highly preferred.

• In-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis.

• Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented to regulatory agencies.

• Knowledge of clinical trial regulatory, ICH GCP, and CDISC requirements. 

• Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data/results with documentation to regulatory agencies.

• Strong leadership skills, commitment and drive to achieve goals.

If you are interested in confidentially exploring this career opportunity, kindly send your resume to me directly at: jedgar@sympatico.ca, 416 225-6386


PRINCIPAL BIOSTATISTICIAN, TO RMB 600,000 PLUS 20,000 TO COVER VARIOUS ALLOWANCES (MEALS, LIVING AND TRANSPORTATION) BASED IN SHANGHAI (PUDONG ZHANGJIANG NEW DISTRICT) CHINA TO START IN NEW YEAR 2019

Our client has opened a third international location in Shanghai and we are searching for several senior talented Biostatisticians who will be accountable for developing, applying and/or providing expertise in clinical trial statistical and programming methods and techniques to effectively manage and complete statistical and programming projects, and to support the company’s mission, strategies, customers and priorities. In addition to the technical accountabilities, this position assumes project management responsibilities in directing and managing statistical and programming team activities for clinical trials from the development of study protocols to the completion of study reports. May represent division and the company, participate in business development and customer relationship management activities, and provide leadership in executing divisional and corporate plans.

  1. Provide leadership/expertise in day to day statistical and programming team operations and in resolving complex problems for assigned projects, or as a consultant to others. 
  2. May represent division or company - provide leadership in major divisional/corporate efforts and in executing divisional or corporate plans. These efforts may include, but not limited to, the following:
    - Providing leadership/expertise in research and development of statistical methodologies.
    -  Investigating and implementing new technologies, processes and procedures.
    - Developing and executing customer relationship management plans.
    - Participating in new business development and bidding processes.
  3. Act as Lead Biostatistician/Teammate Biostatistician to interact with clinical trial sponsor companies, and oversee projects for a sponsor company and/or for given therapeutic areas.
  4. Lead assigned projects by applying project management skills, statistical and programming techniques to deliver quality and timely deliverables.
  5. Plan, develop and monitor timelines for statistical and programming activities in accordance with medical/clinical activities for assigned projects. Jointly with immediate management, assess statistical and programming resource needs and manage the assigned resources to the projects.
  6. Write Statistical Analysis Plans (SAPs) for assigned projects. Perform review on the SAPs written by others.
  7. Provide statistical input into the development of study concept, protocol synopsis, protocol, and protocol amendments.
  8. Perform review of clinical trial documents, including but not limited to the following: study concept sheet, protocol synopsis, protocols and amendments, statistical and programming documents generated by others, and clinical study reports or publications. 
  9. Develop or perform review of statistical programming technical specifications, which include but not limited to the following: clinical trial data handling rules, statistical derivations/algorithms, SDTM and ADaM dataset specifications, and statistical testing/modeling approaches.
  10. Perform quality control (QC) activities on statistical datasets such as SDTM and ADaM datasets. These activities include but not limited to the following: perform independent statistical programming to validate the datasets, perform QC review of the datasets, assess and recommend resolutions on discrepancies between the datasets generated by two Statistical Programmers or Biostatisticians.
  11. Perform quality control (QC) activities on statistical analysis results or data displays such as statistical summary tables, listings, and graphs (TLGs). These activities include but not limited to the following: perform independent statistical programming to validate the TLGs, perform QC review of the TLGs, assess and recommend resolutions on discrepancies between the results generated by two Statistical Programmers or Biostatisticians.
  12. Generate or perform QC on clinical trial patient randomization codes and treatment assignments. Oversee IxRS (IVRS and IWRS) implementation of patient randomization codes and treatment assignments for assigned projects.
  13. Provide statistical and programming input into clinical trial Case Report Forms (CRF) design for assigned projects, and may provide input to the database design data flow, variable naming conventions and data structure, etc. when required.
  14. Participate in clinical trial kick off meeting, investigators meeting, and ongoing trial management team meetings as per project requirements.
  15. Write statistical and results sections of the Clinical Study Report, or perform QC review of the CSR.
  16. Provide statistical and programming support to clinical trial results dissemination activities, such as generation of data reports for abstracts, manuscripts, posters, and presentations, etc.
  17. With assistance from the Archivist, archive study documentation upon the completion of final Study Reports.
  18. Participate and contribute to the training, mentoring, and development of new Biostatisticians or Statistical Programmers.
  19. Adhere to company governing documents (policies, SOPs, work instructions, templates and checklists), may contribute to the further development of these documents.
  20. Contribute to organization development and growth by participating in the interview and evaluation process for job applicants.
  21. Plan and carry out professional development.  

Qualifications and Experience:

A Ph.D. degree or equivalent in statistical science, mathematical analysis or related plus 7 years of relevant experience or a Master’s degree plus 10 years relevant experience with demonstrated ability and sustained performance at the Ph.D. level.

If you are interested in confidentially exploring this opportunity, kindly send your resume to me Cris Murray directly at:  jedgar@sympatico.ca 416 225-6386


SR. BIOSTATISTICIAN, RMB 400,00 TO 500,000 PLUS 20,000 TO COVER VARIOUS ALLOWANCES (MEALS, LIVING AND TRANSPORTATION) BASED IN SHANGHAI (PUDONG ZHANGJIANG NEW DISTRICT) CHINA TO START IN NEW YEAR 2019

Our client has opened a third international location in Shanghai and we are searching for several senior talented Biostatisticians who will be accountable for developing, applying and/or providing expertise in clinical trial statistical and programming methods and techniques to effectively manage and complete statistical and programming projects, and to support the company’s mission, strategies, customers and priorities. In addition to the technical accountabilities, this position assumes project management responsibilities in directing and managing statistical and programming team activities for clinical trials from the development of study protocols to the completion of study reports. May represent division and the company, participate in business development and customer relationship management activities, and provide leadership in executing divisional and corporate plans.

  1. Provide leadership/expertise in day to day statistical and programming team operations and in resolving complex problems for assigned projects, or as a consultant to others. 
  2. May represent division or company - provide leadership in major divisional/corporate efforts and in executing divisional or corporate plans. These efforts may include, but not limited to, the following:
    - Providing leadership/expertise in research and development of statistical methodologies.
    -  Investigating and implementing new technologies, processes and procedures.
    - Developing and executing customer relationship management plans.
    - Participating in new business development and bidding processes.
  3. Act as Lead Biostatistician/Teammate Biostatistician to interact with clinical trial sponsor companies, and oversee projects for a sponsor company and/or for given therapeutic areas.
  4. Lead assigned projects by applying project management skills, statistical and programming techniques to deliver quality and timely deliverables.
  5. Plan, develop and monitor timelines for statistical and programming activities in accordance with medical/clinical activities for assigned projects. Jointly with immediate management, assess statistical and programming resource needs and manage the assigned resources to the projects.
  6. Write Statistical Analysis Plans (SAPs) for assigned projects. Perform review on the SAPs written by others.
  7. Provide statistical input into the development of study concept, protocol synopsis, protocol, and protocol amendments.
  8. Perform review of clinical trial documents, including but not limited to the following: study concept sheet, protocol synopsis, protocols and amendments, statistical and programming documents generated by others, and clinical study reports or publications. 
  9. Develop or perform review of statistical programming technical specifications, which include but not limited to the following: clinical trial data handling rules, statistical derivations/algorithms, SDTM and ADaM dataset specifications, and statistical testing/modeling approaches.
  10. Perform quality control (QC) activities on statistical datasets such as SDTM and ADaM datasets. These activities include but not limited to the following: perform independent statistical programming to validate the datasets, perform QC review of the datasets, assess and recommend resolutions on discrepancies between the datasets generated by two Statistical Programmers or Biostatisticians.
  11. Perform quality control (QC) activities on statistical analysis results or data displays such as statistical summary tables, listings, and graphs (TLGs). These activities include but not limited to the following: perform independent statistical programming to validate the TLGs, perform QC review of the TLGs, assess and recommend resolutions on discrepancies between the results generated by two Statistical Programmers or Biostatisticians.
  12. Generate or perform QC on clinical trial patient randomization codes and treatment assignments. Oversee IxRS (IVRS and IWRS) implementation of patient randomization codes and treatment assignments for assigned projects.
  13. Provide statistical and programming input into clinical trial Case Report Forms (CRF) design for assigned projects, and may provide input to the database design data flow, variable naming conventions and data structure, etc. when required.
  14. Participate in clinical trial kick off meeting, investigators meeting, and ongoing trial management team meetings as per project requirements.
  15. Write statistical and results sections of the Clinical Study Report, or perform QC review of the CSR.
  16. Provide statistical and programming support to clinical trial results dissemination activities, such as generation of data reports for abstracts, manuscripts, posters, and presentations, etc.
  17. With assistance from the Archivist, archive study documentation upon the completion of final Study Reports.
  18. Participate and contribute to the training, mentoring, and development of new Biostatisticians or Statistical Programmers.
  19. Adhere to company governing documents (policies, SOPs, work instructions, templates and checklists), may contribute to the further development of these documents.
  20. Contribute to organization development and growth by participating in the interview and evaluation process for job applicants.
  21. Plan and carry out professional development.  

Qualifications and Experience:

A Ph.D. degree or equivalent in statistical science, mathematical analysis or related plus 5 years of relevant experience or a Master’s degree plus 8 years relevant experience with demonstrated ability and sustained performance at the Ph.D. level.

If you are interested in confidentially exploring this opportunity, kindly send your resume to me Cris Murray directly at:  jedgar@sympatico.ca 416 225-6386


  SENIOR PRINCIPAL PROGRAMMER RMB 500,000 TO 550,000, BASED IN SHANGHAI (PUDONG ZHANGJIANG NEW DISTRICT) CHINA TO START IN NEW YEAR 2019

Our client has opened a third international location in Shanghai and we are searching for several senior talented Principal Programmers who will be accountable for developing, applying and/or providing expertise in clinical trial statistical and programming methods and techniques to effectively manage and complete statistical and programming projects, and to support the company’s mission, strategies, customers and priorities. In addition to the technical accountabilities, this position assumes project management responsibilities in directing and managing statistical and programming team activities for clinical trials from the development of study protocols to the completion of study reports. May represent division and the company, participate in business development and customer relationship management activities, and provide leadership in executing divisional and corporate plans.

Key Accountabilities:

  1. Lead projects with higher level of complexity/challenges/difficulties. Lead efforts to resolve complex statistical programming issues or problems.
  2. Perform a leadership role in statistical programming projects by coordinating study team(s), overseeing timelines, assigning and following up on programming tasks, interacting with clients, and ensuring quality of programming deliverables.
  3. Assist statistical programming management in properly planning and allocating resources based on timelines, statistical programmers’ skills and expertise, as well as availability.
  4. Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical industry standards, conventions, and regulatory requirements.
  5. Perform hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I – IV clinical trials, integrated clinical summaries, responses to requests from regulatory agencies, publication support, data explorations, data monitoring committee meetings, etc.
  6. Create SDTM mapping specifications and ADaM data specifications. Perform quality control (QC) review of these documents prepared by others.
  7. Create SDTM and ADaM define.xml files. Perform QC review of these files prepared by others.
  8. Perform 3rd level QC review on programming deliverables before their release to the clients.
  9. Perform QC review/assessment on regulatory submission programming documents, datasets, tables/listings/graphs (TLGs), and computer programs, etc.
  10. May lead programming efforts for drug development programs or for assigned client clusters.
  11. Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.
  12. Monitor the compliance and adherence to the established data and programming standards, and statistical programming governing documents.
  13. May represent the company in interactions with clinical trial sponsors with regard to statistical programming projects and relevant businesses.
  14. Participate in the development of statistical programming policies, SOPs, guidelines, and good working practices.
  15. Participate in statistical programming project bidding or bid defense meetings.
  16. Work with document management specialists/archivists to plan and perform archival of the statistical programming datasets, outputs, documents, and final programs upon the completion of the assigned projects. Perform transfer of the archived files to the clinical trial sponsors.

Qualifications and Experience:

  1. M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.
  2. 10 (M.Sc., M.A.)/9 (Ph.D.) years' related experience.
  3. An in-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies. Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented. Knowledge of clinical trial regulatory and ICH requirements.
  4. Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies. Must possess in-depth level understanding of the concept of standardization in data, programming, and statistical reporting of trial results, and its implication to the relevant functions and operations. Must have sound technical judgment and experience in process design and implementation in relevant areas. Strong leadership and drive to achieve goals will be required.
  5. If you are interested in confidentially exploring this opportunity, kindly send your resume to me Cris Murray directly at:  jedgar@sympatico.ca 416 225-6386

JUNIOR TO SENIOR BIOSTATISTICIAN RMB 300,000 to 500,000 Based in  SHANGHAI (Pudong Zhangjiang New District), China to start in the New Year 2019

Our client has opened a third international location in Shanghai and we are searching for several junior, intermediate and senior talented Biostatisticians who will be accountable for applying and/or providing expertise in statistical, programming, and data management methods and techniques to effectively enable decision making in support of the company’s mission, strategies, customers and priorities. Key responsibilities: Lead efforts in resolving day to day work related issues and problems, improving efficiency, quality, and productivity of the operation; enhancing customer relationships and improving customer satisfaction. Research and development of statistical methodologies. Investigate and implement new technologies, processes and procedures. Participate in developing and executing marketing strategies and participate in developing and executing customer relationship management plans. Participate in business development and maintenance activities. Perform review for clinical study protocols and statistical, programming, and data management documents generated by others.

  1. Lead assigned projects by applying project management skills, statistical, programming, and data management techniques to facilitate better decision making, improve business operations and discover, improve, develop or defend new or existing products.
  2. Plan, develop and monitor timelines for statistical, programming, and data management activities in accordance with medical/clinical activities for assigned projects. Jointly with immediate management, assess statistical, programming, and data management resource needs and manage the assigned resources.
  3. Provide statistical and data management input into protocol development. Write Statistical Analysis Plans for assigned projects. Oversee IVRS and web-based patient randomization processes for assigned projects.
  4. Oversee the development of Data Management Plans (DMPs) for assigned projects.
  5. Provide statistical input into Case Report Forms (CRF) design for assigned projects, and oversee efforts in developing, reviewing and testing of the CRFs.
  6. Provide statistical and programming input into database design for assigned projects, and oversee efforts in development, validation and testing of the study databases.
  7. Participate in Study Manual Development, and in clinical trial initiation meetings such as investigator meetings, site monitor/coordinator training sessions. Address statistical, programming, and data management questions/concerns from the meeting participants. Train site personnel on data management requirements and procedures.
  8. Oversee data management and programming activities for assigned projects. Serve as primary contact between medical/clinical and data management in data related issues.
  9. Oversee programming support activities for assigned projects. Validate the accuracy, consistency and integrity of the statistical output displays generated by the Study Programmer.
  10. Perform statistical data analyses. Write statistical and data management sections of the joint medical and statistical Study Reports for assigned projects.
  11. With assistance from the Archivist, archive study documentation upon the completion of final Clinical Study Reports.
  12. Participate in evaluating the performance of assigned project personnel.
  13. Follow up on the development and implementation of new statistical, programming, and data management methodologies which will improve current/future decision making or divisional/corporate business processes, and on the statistical/data management related regulatory requirements and practices.
  14. Participate in the development and maintenance of, and adhere to divisional SOPs and guidelines.
  15. Participate in the development and maintenance of, and adhere to therapeutic area specific standards and conventions.
  16. Participate in the development and maintenance of, and adhere to corporate policies and SOPs.
  17. Plan and carry out professional development.

Qualifications and Experience:

A Ph.D. degree or equivalent in Statistical Science, Mathematical Analysis, or related field plus 1 to 2 years relevant experience or a Master’s degree plus 4 to 5 years relevant experience with demonstrated ability and sustained performance.

plus 20,000 to cover various allowances(meals, living and transportation)

Please call Cris Murray 416 225-6386 for all the details. Please send your resume in confidence to : jedgar@sympatico.ca


SENIOR STATISTICAL PROGRAMMERS RMB 300,000 to 450,000 Based in Shanghai (Pudong Zhangjiang New District), China to start in the New Year  2019.
Our client has opened a third international location in Shanghai and we are seeking several talented Statistical Programmers to perform senior level Statistical Programming tasks at a leadership level to drive continued success in this exciting field of clinical research.
Key Accountabilities: Lead study teams by participating in resource planning and managing timelines and deliverables. This includes managing programming assignments for project team members and following up on task status to ensure deliverables are completed on time and with quality. Prepare SDTM data mapping specifications, ADaM dataset specifications, data reviewer’s guides and define.xml documents. Perform QC review of these documents prepared by others. Program SDTM and ADaM datasets according to approved dataset specifications. Generate complete and accurate statistical tables, listings, and graphs (TLGs) in accordance with Statistical Analysis Plan (SAP) and well-defined formats. Document data and programming information in accordance with SOPs and/or clinical trial sponsor’s specific requirements. Perform independent SAS programming validation of datasets and TLGs programmed by others. Perform 3rd level QC review and programmatic checks on programming deliverables before releasing them to clients. Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming. Archive clinical trial data (raw data, SDTM, and ADaM datasets) and programming documentation in accordance with SOPs and/or clinical trial sponsor’s specific requirements. Actively contribute to the continuous improvement of clinical data standards, conventions and statistical programming SOPs. Design and implement SAS macros to enable standardization and efficiency in statistical programming.

Qualifications and Experience:

A Master’s degree in Statistics, Biostatistics, Bioinformatics, Computer Sciences, Mathematics, or other relevant fields is required with at least five years of relevant industry experience using SAS in clinical trial analysis and reporting.  A College English Test (CET) 6 certificate is highly preferred. In-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis. Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented to regulatory agencies. Knowledge of clinical trial regulatory, ICH GCP, and CDISC requirements. Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data/results with documentation to regulatory agencies. Strong leadership skills, commitment and drive to achieve goals. This position is expected to perform a leadership role in statistical programming and reporting areas. Incumbents in this role receive highly competitive compensation and benefits. Highly driven, team-oriented, and quality-focused individuals have the potential to advance to technical or business leadership positions.

Tasks are performed in a timely, accurate, and efficient manner to ensure quality and productivity. Deliverables will conform with regulatory submission standards from CDISC, FDA, EMA, CFDA, PMDA, and other regulatory agencies.

Please call Cris Murray 416 225-6386 for all the details. Please send your resume in confidence to : jedgar@sympatico.ca


JUNIOR STATISTICAL PROGRAMMERS  RMB 150,000 to 180,000 Based in  SHANGHAI (Pudong Zhangjiang New District), China to start in the New Year 2019.

Our client has opened a third international location in Shanghai and we are searching for a talented Statistical Programmer to perform entry level statistical programming tasks with opportunities for training and development. Highly driven, team-oriented, and quality-focused individuals have the potential to advance to levels of increasing responsibility and visibility and to receive highly competitive compensation. Tasks are performed in a timely, accurate, and efficient manner to ensure quality and productivity as our client specializes in Clinical Research.

This role requires performing data conversion between datasets with two different formats according to conversion requirements/specifications, e.g. converting from Excel data records to SAS datasets, non-CDISC compliant datasets to CDISC compliant datasets. Assist in developing SDTM data mapping specifications. Program SDTM and ADaM datasets according to approved dataset specifications. Generate complete and accurate statistical tables, listings, and graphics (TLGs) in accordance with Statistical Analysis Plan (SAP) and well-defined formats. Develop and test SAS programming codes for clinical trial database logical checks and data reports for ongoing data review. Perform SDTM CRF annotation (aCRF) or QC activities on aCRFs generated by others. Document data and programming information in accordance with SOPs and/or clinical trial sponsor’s specific requirements. Archive clinical trial data (raw data, SDTM, and ADaM datasets) and programming documentation in accordance with SOPs and/or clinical trial sponsor’s specific requirements.

Qualifications and Experience:

A Master’s degree in Statistics, Biostatistics, Bioinformatics, Computer Sciences, and Mathematics, or other relevant fields is required with at least one year experience of using SAS. SAS certified Base, Advanced, and Clinical Trials Programmers are highly preferred. A College English Test (CET) 6 certificate is highly preferred.

Please call Cris Murray 416 225-6386 for all the details. Please send your resume in confidence to : jedgar@sympatico.ca


 

 Pharmaceutical   Manufacturing | Technology Marketing |  Resume |