Job Description
Job Description
Title: Clinical SAS Programmer
Location: Remote (Pacific hours)
Duration: 6+ Months - Long Term (40 hrs/week)
Day‐to‐Day Responsibilities
- Create SAS data listings and review outputs directly from raw clinical data (pre‐SDTM), supporting rapid internal data review.
- Design, develop, validate, and maintain complex SAS programs and reusable macro frameworks to support clinical research analysis and reporting.
- Perform appropriate verification/validation of programming and reporting activities; review and provide input on project requirements and documentation.
- Provide advanced troubleshooting for SAS macro‐related issues, including root cause analysis and longer‐term remediation.
- Serve as Lead Clinical Programmer or Program Programming Lead as needed across studies or programs.
- Review and ensure quality, compliance, and consistency of multi‐study and program‐level deliverables.
- Lead or contribute to process improvement, automation, and code standardization initiatives within Biometrics.
- Work directly with EDC data (e.g., Rave/Medidata) to support data cleaning, review, and data quality checks.
- Partner closely with Data Management, Clinical Operations, and Medical teams to understand questions and translate them into analytic outputs.
- Deliver quick-turn, ad hoc analyses and listings to support ongoing studies and internal decision‐making.
- Operate with minimal oversight: produce clean, reliable outputs without needing a separate QC programmer, while remaining flexible and creative in approach.
Must‐Have Experience
- 8+ years of clinical SAS programming / DM‐focused SAS experience in Pharma, Biotech, and/or CRO settings.
- At least 50% of career experience focused on Data Management and raw data, not only standard TLF/statistical outputs.
- Strong understanding of Data Management workflows and raw (pre‐SDTM / CDASH) clinical data.
- Proven ability to generate data listings and review outputs using SAS from raw/EDC data.
- Advanced SAS macro development expertise, including framework and utility macro design.
- Experience with SAS code optimization and performance tuning.
- Demonstrated experience in code standardization and framework development across studies or programs.
- Experience working directly with EDC systems (e.g., Rave/Medidata or similar); comfortable navigating and extracting raw data.
- Comfortable writing SAS, and ideally R and Python, to create listings and custom outputs from raw data.
- Track record of success in fast-paced, evolving biotech environments, particularly in smaller companies or startups.
- Strong communication skills; able to clearly explain how they’ve worked with raw data and Data Management teams (not just standard stat programming).
- Bachelor’s degree (B.S./B.A.) in a quantitative or life sciences discipline.
Nice‐to‐Haves
- Prior experience in smaller company / startup biotech or small CROs, where roles are broad and hands‐on.
- Experience working closely with Biometrics and cross‐functional clinical/regulatory stakeholders.
- Background spanning both Data Management‐oriented programming and traditional statistical programming, with emphasis on raw data.
- Experience standardizing SAS/R/Python codebases and building reusable programming frameworks across multiple studies.
- Demonstrated ability to innovate and automate within Biometrics (e.g., macro libraries, automated listings, QC frameworks).
Ideal Candidate Snapshot
A senior Clinical SAS Programmer / Data Management‐focused programmer who has spent a significant portion of their career working directly with raw CDASH-level and EDC data, not just polished SDTM/ADaM datasets. They are deeply familiar with Data Management workflows, can independently design and build SAS macro frameworks, and are comfortable using SAS, R, and Python to create listings and custom outputs at speed. This person thrives in smaller, fast‐moving biotech or small CRO environments, where they work directly with Biometrics, Data Management, Clinical Ops, and Medical teams to answer real‐time questions. They do not rely on a separate QC partner they own the full cycle from raw data to clean, decision‐ready outputs and can clearly articulate how they’ve partnered with Data Management and worked with raw EDC data in prior roles. They are flexible, creative, and able to plug in quickly to help this biotech stabilize and accelerate internal data review through EOY.