Senior/Principal Statistical Programmer
C
ClinChoiceClinical research
Remote in UKFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English (essential); French (preferred)
- Experience
- 8+ years of statistical programming experience in a pharmaceutical, biotechnology, or CRO environment supporting clinical development.
- Required Skills
- R
Requirements
- 8+ years of statistical programming experience in a pharmaceutical, biotechnology, or CRO environment supporting clinical development.
- Strong proficiency in SAS programming.
- Strong understanding of CDISC standards, including SDTM and ADaM.
- Hands-on experience specifying, developing, and programming SDTM and ADaM.
- Strong experience in TFL programming and reporting.
- Experience supporting clinical trial reporting and/or regulatory submissions.
- Experience working with complex clinical trial data and study designs.
- Ability to provide technical leadership and independently manage programming activities across multiple studies.
- Bachelor’s or master’s degree in Statistics, Mathematics, or a scientific discipline.
- Experience in Oncology, Rare Disease, or Neuroscience is preferred.
- R or other packages are desired.
- Experience in NDA/sNDA submissions is desired.
- English is essential; French is preferred.
Responsibilities
- Lead statistical programming for multiple studies and compounds, ensuring high-quality and timely delivery.
- Lead and execute programming activities across clinical trials from study start-up through database lock, reporting, and regulatory submission.
- Develop, review, and validate TLFs, SDTM and ADaM datasets, and associated documentation, including Define-XML.
- Provide technical oversight of outsourced programming activities and monitor quality, budget, and timelines.
- Support global regulatory submissions and responses to health authority questions.
- Develop, perform quality control for, and document statistical programs using SAS.
- Contribute to SAS programming standards, SOPs, work instructions, and best practices.
- Collaborate with statisticians and cross-functional teams to translate study designs, endpoints, and analysis requirements into programming solutions.
- Provide technical guidance and mentoring to statistical programmers.
- Maintain study programming documentation in accordance with company processes and inspection and audit requirements.
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