Principal Statistical Programmer

  • Full Time
  • NA

Website Pharmaron

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 responses 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 projects

    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.

 

Contact:

Please submit your resume and CV to mia.terwilliger@pharmaron.com and mention that you saw this JD on the SAPA website. 

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