Department

Statistical Programming

Responsibilities

1. Perform SAS data processes and analysis programming.

2. Works with Statistician and Statistical programmer to assure results are consistent with expectations, and Quality control procedures are followed.

3. Lead the development and delivery of training.

4. Act as primary contact to ensure that company standards are implemented in all studies.

5. Works collaboratively to meet study deliverables and timelines for statistical data analysis and reporting.

6. Plans and carefully documents differences between programming results between program developer and Statistical QC programmer.

7. Provided programming support on ISS/ISE and post-submission activities.

8. Provide flexible and rapid response to programming requests.

9. Ensure consistency and adherence to standards within the project.

10. Confirms that tracking sheets are current for projects, and confirm that results are consistent with earlier generated results.

11. Maintain up-to-date study documentation.

12. Identify opportunities to improve the methodology and provide practical solutions for problems.

13. Develop, program, test, and maintain computer validation/edit checks in SAS.

14. Validate peer programming.

15. Provide technical expertise and support to the Data Management team.

16. Routinely interface with cross-functional team members.

17. Participate in regular team meetings and provide input when appropriate.

18. Participate in the development of clinical programming SOPs and the development/optimization of clinical programming processes from study start-up to database lock.

19. Managing project priorities and timelines.

20. Have good knowledge of statistical terminology, clinical data structure, clinical tests, medical terminology, regulatory standards, and protocol designs.

21. Review programming activities and costs in contracts.

22. Direct responsibility for supervising and training junior clinical programmers in the performance of their duties

Qualification

1. BS degree or higher in programming or statistics.

2. SAS Experience in Pharmaceutical or equivalent: >=5 years Oncology experience preferred.

3. Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.

4. Knowledge of CDISC standards and industry best practices.

5. Have good knowledge of statistical terminology, clinical data structure, clinical tests, medical terminology, regulatory standards and protocol designs.

6. Strong SAS programming / Macros development / SAS graphs skills.

7. Excellent oral and written skills for cross-site and cross-function collaboration.

8. Dependable, motivated, focused, and detail orientated.

9. Ability to take direction as needed and work independently on project when necessary.

10. Capable of managing time effectively and adhering to timelines and project schedules Complementary Skills.

11. Working knowledge of SAS modules and utilities.

12. Ability to develop routines using the SAS Macro Language.

13. Strong SAS programming / Macros development / SAS graphs skills.

14. Understanding of biotech industry regulatory requirements.

15. Ability to use Microsoft Office tools: Word, Excel, PPT, etc.