Senior Statistical Programmer, Validation & Qualification

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.