Scope
The Associate Director of Statistical Programming provides strategic and operational leadership for all statistical programming activities within and across clinical development programs. This role is responsible for ensuring timelines and the quality standards for programming deliverables are met. They will serve as the primary statistical programming representative in cross-functional teams and lead programming related activities for regulatory submissions (INDs, IBs NDA/BLAs, etc.), clinical study reports, abstracts, and publications. This role may supervise junior statistical programmers.
Reports to: VP of Biometrics and Data Management
Location: Kirkland, WA (hybrid work environment)
Key responsibilities and duties:
- Lead statistical programming activities across one or more clinical development programs
- Program and validate deliverables for interim and final analyses, publications, abstracts, CSRs, and regulatory submissions
- Collaborate with study biostatisticians to develop and implement TLF programming for statistical analysis plans
- Assist data management in the development and programming of non-system edit checks for clinical trial data
- Develop and maintain the statistical programming environment for biometrics
- Provide hands-on oversight of CROs and external statistical programming groups to ensure quality standards and timelines are met for programming related deliverables
- Develop SOPs for statistical programming function
Education, qualifications and work experience:
- Bachelor's degree or higher
- 15+ years of biotech/pharma experience as a statistical programmer
- Expert level knowledge of CDISC standards (SDTM, ADaM) and SAS®
- Experience preparing study data and output for regulatory submissions
- Demonstrated experience supporting pivotal and registrational clinical trials
- Strong CRO and vendor oversight experience
- Track record of delivering high-quality programming related deliverables
- Strong experience with Pinnacle 21
Additional attributes:
Salary Range: $160,000 to $190,000 depending on education and relevant experience.
