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Senior/Principal Statistical Programming
ClinChoice. Serve as a lead statistical programmer for multiple studies and/or compounds .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates strong proficiency in SAS programming and a deep understanding of CDISC standards, particularly SDTM and ADaM, while providing technical leadership in statistical programming for clinical trials. Capable of managing programming activities independently and ensuring high-quality deliverables for regulatory submissions.
Highest-signal resume keywords
SAS ProgrammingCDISC StandardsStatistical Programming LeadershipClinical Trial ReportingTFL Programming
ATS Keywords
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Hard Skills
SAS ProgrammingTFL ProgrammingSDTM DevelopmentADaM DevelopmentStatistical AnalysisProgramming DocumentationQuality ControlProcess ImprovementRegulatory Submission SupportComplex Study Design
Soft Skills
Technical LeadershipCollaborationMentoringCommunicationProblem Solving
Tools & Technologies
SASDefine-XMLStatistical Software PackagesClinical Trial Management Systems
Industry Keywords
PharmaceuticalBiotechnologyCROOncologyRare DiseaseNeuroscienceNDA SubmissionSNDA Submission
About the role
Key responsibilities & impact- Serve as a lead statistical programmer for multiple studies and/or compounds
- Lead and execute statistical programming activities across clinical trials from study start-up through database lock, reporting, and regulatory submission
- Ensure consistency, quality, and timely delivery of programming deliverables
- Support global regulatory submissions and responses to health authority questions
- Provide technical oversight and guidance for outsourced statistical programming activities
- Develop, review, and validate tables, listings, figures (TLFs), SDTM/ADaM datasets, and Define-XML documentation
- Develop, QC/validate, and document SAS programs
- Contribute to SAS programming standards, SOPs, work instructions, and best practices
- Maintain study-related programming documentation in accordance with Ipsen processes and keep it inspection/audit ready
- Collaborate with statisticians, clinical teams, data management, and cross-functional stakeholders
- Provide technical guidance and mentoring to other statistical programmers
- Identify process improvements and support complex study design methodologies
- Act as a statistical programming subject matter expert and contribute to technical decision-making
Requirements
What you’ll need- Strong proficiency in SAS programming within a pharmaceutical, biotechnology, or CRO environment
- Strong understanding of CDISC standards, including SDTM and ADaM
- Hands-on experience with SDTM and ADaM specification, development, and programming
- 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
- 8+ years of statistical programming experience in a pharmaceutical, biotechnology, or CRO environment supporting clinical development
- Bachelor or MSc in Statistics, Mathematics, or Scientific Discipline
- English
- Experience in Oncology, Rare Disease, or Neuroscience preferred
- R or other packages desired
- Experience in NDA/sNDA submission desired
- French preferred
Benefits
Comp & perks- Security and additional career opportunities through working for a global CRO
- Continuous training and development
- Close management and training
- Equal opportunity employer committed to diversity and inclusivity