Director/Associate Director, Statistical Programming

CymaBay is a clinical stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases. 

If you are ready to join a team where your work is challenging, rewarding and meaningful; where your efforts are recognized and appreciated; where your career and skills are developed and expanded; AND where you are truly VALUED…

then CymaBay is looking for YOU!

To help us achieve our mission we are seeking a talented Associate Director/Director, Statistical Programming to join our team. The position will be accountable for internal statistical programming planning and activities for clinical development; development and maintenance of internal SAS programming platform, provide strategic input in Biometrics planning, and oversee vendors’ programming deliverables.

Essential Functions and Job Responsibilities:

  • Lead statistical programming function to support clinical development
  • Develop and maintain SAS programming infrastructure and process to ensure the quality and compliance in statistical programming deliverables
  • Establish programming and QC processes, create related SOPs
  • Provide training on departmental SOPs/WPs and programming standards
  • Create SAS macro/application to streamline processes
  • Lead development of SDTM and ADaM specification and datasets for clinical studies
  • Review related clinical study documents and provide statistical programming feedback
  • Execute statistical analysis plan, generate SAS outputs
  • Create and maintain documentation for programming activities
  • Oversee CRO’s activities, review CRO’s programming deliverables to ensure the quality
  • Contribute to the development of Biometrics and Clinical Operation and Development processes and procedures
  • Understand importance of timelines and strive to meet them
  • Recruit, develop, and supervise statistical programming resources

 

 

Minimum Qualifications:

  • BA/MA/PhD in biostatistics, statistics, mathematics, computer science, or similar discipline
  • 10+ years’ experience in clinical programming in the biotechnology pharmaceutical or health related industry
  • 5+ years’ experience in direct line management and/or vendor management
  • Successful experience with BLA/NDA
  • Advanced SAS programming skills and in-depth knowledge of CDISC standards
  • Knowledge in implementation and validation of SAS programming platform
  • Must be able to work productively in a fast-paced collaborative environment