About the Role
- Plays a lead role in designing, developing, testing, maintaining, validating, and documenting SAS programs to evaluate clinical data and meet SAS statistical programming requirements for clinical and non-clinical projects/studies.
- Provides advanced technical expertise to develop programming standards and procedures.
- On-site role (ideal candidate lives in the San Diego area).
Your Contributions
- Provide advanced statistical programming leadership and serve as a technical resource for statistical programmers.
- Participate in hiring, training, and oversight of statistical programmers.
- Serve as lead on large, multidisciplinary projects; primary Statistical Programming point of contact.
- Provide technical direction for programming standards/conventions and programming infrastructure.
- Assess workload/projects to ensure adequate programming resources.
- Oversee and validate vendor programming activities (e.g., CDISC implementation, analysis reporting, programming conventions).
- Support e-submission requirements (annotated CRF, dataset files, define documents).
- Serve as primary/lead programmer for agency reporting deliverables (e.g., DSUR/Annual Report and IB updates).
- Perform lead and/or quality control statistical programmer activities as needed.
Requirements
- BS/BA in CS/Math/Statistics or related + 6+ years biopharma (or CRO) statistical programming (advanced SAS: Base/Stat/Macro/graph; CDISC data structures) AND 3+ years supervisory/lead experience managing large projects and external vendors.
- OR Masterβs + 4+ years.
- OR PhD + 2+ years.
- Advanced SAS and SOP/process development in clinical environments; ability to write/validate/document statistical programs and create programming libraries/systems.
- Knowledge of ICH, CDISC, 21 CFR Part 11, FDA guidelines; relational databases; SDTM, ADaM, and Define.xml/specification file creation.
- Proficient with Word, Excel, PowerPoint; excellent communication, problem-solving, analytical thinking, and project management.
Benefits
- Annual bonus (target 30% of earned base salary) and eligibility for equity-based long-term incentive.
- Retirement plan with company match; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; health benefits (medical/prescription/dental/vision).
Application instructions
- Apply for the on-site role (encouraged even if not all qualifications match).