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