Principal Clinical Statistical Programmer (Portfolio Development / Biometrics / Programming)

CSL; Maidenhead; Vor Ort; GBP 90.000 - 130.000; Vollzeit

Zusammenfassung

CSL in Maidenhead is seeking a Principal Programmer to take technical ownership of statistical programming across a programme of trials. You’ll set how the programming is done across multiple studies, lead both in-house and CRO work, and ensure submission-ready data packages.

You will mentor other programmers and shape standards for integrated analyses, while remaining hands-on when required. This hybrid role is based in Maidenhead with three days onsite.

Qualifikationen

• Extensive statistical programming experience across multiple studies
• Lead programmer responsibility across multiple trials
• Expert SAS proficiency (Base/Macro/Stat/Graph) and familiarity with R
• Strong knowledge of CDISC standards (CDASH, SDTM, ADaM, define.xml)
• Experience supporting regulatory submissions end to end
• Experience overseeing CRO/vendor programming

Aufgaben

• Lead programming at the programme level, across in-house and outsourced studies, from study setup through integrated analyses and regulatory submission
• Set direction for other programmers, internal and external, and help shape how the wider programming function works
• Define programming strategy for outsourced studies, set expectations for CROs and hold their deliverables to submission standard
• Act as the programming point of contact for regulatory submissions and agency queries
• Lead and mentor other programmers, providing technical direction and day-to-day guidance
• Contribute to departmental standards, macros, tools and process improvement including adoption of new approaches such as R-based workflows
• Take on hands-on programming and ad hoc analytical work as required

Kenntnisse

SAS

R language

CDISC standards

Lead programmer

Regulatory submissions

Mentoring

Team leadership

Data integration

Analytical thinking

Ausbildung

BSc in CS/Math/Stats

MSc desirable

Tools

SAS

define.xml

R

Jobbeschreibung

**The Role** CSL is looking for a Principal Programmer to take technical ownership of statistical programming across a compound or programme, not just a single study. You’ll be the person who sets how the programming gets done across multiple trials and through to submission, and the one a study team, a CRO or a regulator’s question ultimately lands with. This is still a hands-on role, and you’ll write and validate code when the work calls for it. Most of your impact, though, comes from the decisions upstream: how standards are applied across studies so an integrated analysis comes together cleanly, how CRO work is scoped and held to account, and how a submission package is built so it holds up under review. You’ll work as a peer to biostatistics, data management, medical writing and regulatory leads, and you’ll be in the room early enough to shape a programme’s analysis strategy rather than inherit it. ***Hybrid Based (3 days a week onsite) in Maidenhead*** **Why It Matters** A single well-programmed study is valuable. A programme where every study was built to the same standard, so pooled safety and efficacy analyses come together without months of rework, is what gets a submission over the line. This role sits at that level. You spot the inconsistency between two studies’ ADaM conventions before it becomes an ISS problem, push back on a CRO deliverable that technically meets spec but won’t survive a reviewer, and make the call on the trade-offs between speed, consistency and regulatory defensibility. When an agency query comes back, you’re the one who knows why the data was built the way it was. **What You’ll Be Responsible For** You’ll lead programming at the programme or compound level, across in-house and outsourced studies, from study setup through integrated analyses and regulatory submission. You’ll set direction for other programmers, internal and external, and help shape how the wider programming function works.* Serve as lead programmer for a compound or programme, overseeing programming across multiple clinical trials and ensuring consistency of standards and approach* Lead the planning, specification and delivery of integrated analyses (ISS/ISE) and pooled datasets, and own the submission-ready data package, including define.xml, reviewer guides (cSDRG/ADRG) and conformance checks* Define programming strategy for outsourced studies, set expectations for CROs and hold their deliverables to submission standard* Act as the programming point of contact for regulatory submissions and agency queries, working with biostatistics and regulatory colleagues on responses* Lead and mentor other programmers, providing technical direction, review and day-to-day guidance across the programme* Contribute to departmental standards, macros, tools and process improvement, including the adoption of new approaches such as R-based workflows* Take on hands-on programming and ad hoc analytical work (exploratory analyses, publication support, regulatory responses) as the programme requires **Experience Required*** Substantial statistical programming experience in pharmaceutical, biotech, CRO or clinical research settings, including lead programmer responsibility across multiple studies* Expert SAS proficiency (Base/Macro/Stat/Graph); working experience with R or other languages is a strong plus* Deep, practical knowledge of current CDISC standards (CDASH, SDTM, ADaM, define.xml) and how to apply them consistently across a programme* Track record of leading integrated analyses (ISS/ISE) and delivering submission-ready data packages* Direct experience of supporting regulatory submissions end to end (FDA required; PMDA, NMPA or EMA experience a plus), including responding to agency queries* Experience of setting direction for and overseeing CRO and vendor programming work* Experience of leading, mentoring or technically directing other programmers* BSc in Computer Science, Mathematics, Statistics or a related field (MSc desirable); equivalent experience and certifications will also be considered