Portfolio Clinical Analytics Lead Programmer

CSL; Maidenhead; Hybrid; GBP 90,000 - 130,000; Full time

Job summary

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.

Qualifications

• 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

Responsibilities

• 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

Skills

SAS

R language

CDISC standards

Lead programmer

Regulatory submissions

Mentoring

Team leadership

Data integration

Analytical thinking

Education

BSc in CS/Math/Stats

MSc desirable

Tools

SAS

define.xml

R

Job description

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.