Associate Director Statistical Programming

Associate Director Statistical Programming

San Francisco, California, United States · QED Therapeutics

Description

We are seeking a highly motivated individual to join the QED Biometrics team. This position will be responsible for managing study related statistical programming activities as well as developing, maintaining, and modifying SAS programs to generate and validate study and ad-hoc specific listings, summary tables and figures for clinical analyses.


Duties and Responsibilities:

  • Write or review SDTM and ADaM specifications prepared in-house or by CROs.
  • Develop, maintain, and modify SAS programs for publication, Investigator Brochure (IB), Development Safety Update Report (DSUR), and ad-hoc analyses.
  • Validate SDTM, ADaM, and tables/listings/graphs generated in-house or by CROs.
  • Review CRFs, edit check specification, data transfer plan, and statistical analysis plan.
  • Collaborate and coordinate the development of study plan and timeline with various internal departments and CROs.
  • Manage and monitor CROs by providing guidelines on study programming activities.
  • Ensure programming deliverable in-house or by CROs.
  • Exercise independent judgement in developing methods, techniques, and evaluation criteria for obtaining results.
  • Design and develop internal standard macro utilities.
  • Develop statistical programming standard operating procedures (SOPs) and work instructions.
  • Other duties as assigned.

Experience:

• 10+ years of industry experience with a minimum 5 years Pharmaceutical/Biotech programming experience

• Solid Technical skills with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat

• Experience as a senior statistical programmer level in a FDA regulated pharmaceutical or CRO environment

• Experience with CDISC standard required • Knowledge of advanced statistical procedures in SAS including LIFETEST, PHREG, MIXED, and GLM.

• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment

• Communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email. Additional Information

Education:

BS in Statistics, Math or Scientific Discipline

If you are passionate about innovation and looking to join a thriving team, email your cover letter and resume to:careers@QEDTx.com

careers

Associate Director Statistical Programming