Senior/Principal Statistical Programmer

ClinChoice

. Serve as lead statistical programmer for multiple studies and/or compounds .

Posted 10/7/2026contractRemoteSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in SAS programming and statistical analysis within the pharmaceutical industry, ensuring high-quality deliverables for regulatory submissions and clinical trials. Capable of providing technical leadership and mentoring while adhering to CDISC standards and best practices.

Highest-signal resume keywords

SAS ProgrammingCDISC StandardsStatistical Programming LeadershipClinical Trial ReportingTFL Programming

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical ProgrammingSDTM DevelopmentADaM DevelopmentQC/ValidationData ManagementStatistical AnalysisProgramming StandardsProcess ImprovementTechnical DocumentationComplex Study Design

Soft Skills

CollaborationMentoringTechnical GuidanceCommunicationProblem-Solving

Tools & Technologies

SASRDefine-XML

Industry Keywords

PharmaceuticalBiotechnologyCROOncologyRare DiseaseNeuroscienceNDA SubmissionSNDA SubmissionClinical DevelopmentHealth Authority Submission

About the role

Key responsibilities & impact

Serve as lead statistical programmer for multiple studies and/or compounds
Lead and execute statistical programming activities from study start-up through database lock, reporting, and regulatory submission
Ensure quality, consistency, 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, SDTM/ADaM datasets, and Define-XML documentation
Develop SAS programs, perform QC/validation, and document statistical programming
Contribute to SAS programming standards, SOPs, work instructions, and best practices
Maintain study 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's or MSc degree in Statistics, Mathematics, or Scientific Discipline
English language required
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 of working for a global CRO
Continuous training and professional development
Close management and training
Equal opportunity and diversity/inclusivity commitment