Manager, Statistical Programming

Responsibilities:
- Review analysis plans for appropriate methodologies
- Review clinical data as SDTM datasets
- Develop analysis databases (ADaM)
- Program study analyses and review study results
- Conduct ad-hoc and exploratory statistical analysis and support manuscript preparation
- Communicate project requirements for data cleanup and data capture to ensure key variables are suitable for analysis
- Assist in developing and implementing departmental standards, applications, processes, and training
- Identify consultants/select service providers and oversee statistical and programming deliverables by CROs or service providers

Requirements:
- Master’s degree in Biostatistics/Statistics
- 4 years of relevant programming experience in pharmaceutical or biotechnology drug development
- Proficiency with SAS; familiar with R Studio
- Excellent verbal and written communication skills; effective cross-functional collaboration and influence
- Understanding and experience across the clinical development life cycle through regulatory submission and post-approval activities
- Experience interacting with and overseeing programming services of CRO vendors
- Knowledge of cross-functional department functions/roles within a drug development company

Preferred:
- Understanding of regulatory guidelines for CDISC dataset submission; experience developing SDTM and ADaM specifications

California pay range: $145,000 USD - $160,000 USD

Candidates must have current, valid authorization to work in the country where this role is located.