About the role
We place experienced statistical programmers directly into sponsor biometrics teams. This role is for someone who does validation as a discipline, not as an afterthought — the programmer who reconciles a stubborn ADaM discrepancy, then explains to a QA auditor exactly why the output can be trusted.
You will validate SDTM, ADaM and TLF deliverables across client studies, and you will own a second, less common responsibility: qualifying that our clients' SAS programs produce identical, defensible results as their statistical computing environments move between Windows and Linux, absorb OS and SAS version updates, and transition to UTF-8 encoding.
That combination is unusual. If you have lived through a platform migration and know why a study that ran clean on Windows suddenly sorts differently on Linux, this posting is written for you.
What you'll do
Validation of study deliverables
- Perform independent (double) programming validation of SDTM domains, ADaM datasets and TLFs against approved specifications, the SAP and CDISC implementation guides.
- Investigate and resolve PROC COMPARE discrepancies to root cause, distinguishing genuine defects from specification ambiguity, and drive the specification correction where that is the real issue.
- Review dataset specifications, define-XML and reviewer's guides for internal consistency and conformance; interpret and clear Pinnacle 21 findings rather than simply reporting them.
- Maintain validation documentation to sponsor SOPs and GxP expectations — validation plans, test scripts, expected versus actual results, traceability and deviation logs.
Cross-platform qualification and change control
- Design and execute test strategies confirming that SAS programs produce equivalent results on Windows and Linux, covering the differences that actually bite: character sort order and collating sequence, case-sensitive paths and file naming, line-ending handling, numeric precision, and RTF/PDF output rendering and fonts.
- Support UTF-8 encoding migration — transcoding and CEDA behaviour, character truncation from multi-byte data, variable and dataset encoding attributes, ENCODING= options, and the K-functions needed where byte-length and character-length diverge.
- Assess the impact of OS patches, SAS version upgrades and environment changes; define regression scope, execute requalification testing, and document outcomes for change control.
- Contribute to installation, operational and performance qualification (IQ/OQ/PQ) activities and support client audits and inspection readiness.
Macro and standards work
- Validate and maintain reusable SAS macros and standard macro libraries, including unit-level testing and version control.
- Recommend improvements to validation approach, test coverage and documentation practice as you move between client environments.
What you'll bring
Required
- 8+ years of statistical programming in clinical trials, with substantial time in a validation or QC capacity.
- Strong SAS: Base, macro language, PROC SQL and reporting procedures. You write macros, and you can read someone else's.
- Demonstrated understanding of clinical study development — protocol, SAP, CRF and study design, and how those decisions propagate into SDTM, ADaM and TLF specifications. This is essential; we are not looking for a programmer who works only from specifications handed down.
- Working knowledge of CDISC standards (SDTMIG, ADaMIG, define-XML) and their application in regulated deliverables.
- Practical experience running SAS in both Windows and Linux environments.
- Familiarity with GxP documentation practice, 21 CFR Part 11 and computer system validation principles.
- The independence to work embedded in a client team, adapt to unfamiliar SOPs quickly, and communicate findings clearly to statisticians, data managers and QA.
Nice to have — not required
- Reading-level understanding of R or Python, enough to interpret or cross-check analyses written in them.
- Prior involvement in a statistical computing environment migration or encoding conversion project.
- Experience with SCE platforms (SAS Life Science Analytics Framework, Domino, or similar), Git or other version control.
- Regulatory submission experience.
Compensation and terms
- $95 – $120 per hour, depending on experience and depth of validation/qualification background.
- Six-month contract at full-time hours (approximately 1,040 hours), with extension possible depending on client demand.
- Fully remote for the duration of the engagement.
- Engagement basis: [W-2 / 1099 / corp-to-corp — specify].