Senior/Principal Statistical Programmer
C
ClinChoiceClinical development
Location: European UnionContractPrincipal
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
- Have 8+ years of statistical programming experience in a pharmaceutical, biotechnology, or CRO environment supporting clinical development.
- Demonstrate strong proficiency in SAS programming.
- Understand CDISC standards, including SDTM and ADaM.
- Have hands-on experience with SDTM and ADaM specification, development, and programming.
- Have strong experience in TFL programming and reporting.
- Have experience supporting clinical trial reporting and/or regulatory submissions.
- Have experience working with complex clinical trial data and study designs.
- Be able to provide technical leadership and independently manage programming activities across multiple studies.
- Hold a Bachelor’s or MSc in Statistics, Mathematics, or a scientific discipline.
- English is essential; French is preferred.
- Experience in Oncology, Rare Disease, or Neuroscience is preferred.
- R or other packages, clinical data flow knowledge, and NDA/sNDA submission experience are desired.
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/ADaM datasets, and associated documentation, including Define-XML.
- Support global regulatory submissions and responses to health authority questions.
- Provide technical oversight of outsourced programming activities and monitor deliverable quality, budget, and timelines.
- Collaborate with statisticians and cross-functional teams to translate study designs, endpoints, and analysis requirements into programming solutions.
- Maintain study programming documentation in accordance with company processes and inspection-readiness expectations.
- Contribute to SAS programming standards, SOPs, work instructions, and best practices.
- Provide technical guidance and mentoring to other statistical programmers.
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