2027 Hiring Opportunities – Senior/Principal Statistical Programming(Remote in EU)

Main Responsibilities & Technical Competencies

• Serve as a lead statistical programmer for multiple studies and/or compounds, ensuring high-quality and timely delivery of statistical programming activities.
• Lead and execute statistical programming activities across clinical trials, from study start-up through database lock, reporting, and regulatory submission.
• Ensure consistency, quality, and executional excellence across programming deliverables for assigned studies.
• Support programming activities for global regulatory submissions and responses to health authority questions.
• Provide technical oversight and guidance for outsourced statistical programming activities, ensuring deliverables meet required quality, budget, and timeline expectations.
• Develop, review, and validate high-quality statistical programming deliverables, including tables, listings, figures (TLFs), SDTM/ADaM datasets, and associated documentation such as Define-XML.
• Provide technical expertise in SAS programming, including development, QC/validation, and documentation of statistical programs.
• Contribute to the development, implementation, and continuous improvement of SAS programming standards, SOPs, work instructions, and best practices.
• Ensure study-related programming documentation is maintained in accordance with Ipsen processes and is inspection/audit ready.
• Collaborate with statisticians and cross-functional teams to understand complex study designs, endpoints, and analysis requirements and translate them into robust programming solutions.
• Provide technical guidance and mentoring to other statistical programmers and contribute to the development of programming capabilities within the organization.
• Identify opportunities to improve programming processes, adopt innovative and efficient approaches, and support evolving and complex study design methodologies.
• Act as a subject matter expert in statistical programming and contribute to technical decision-making within assigned studies and therapeutic areas.

Behavioural Competencies Required

• Collaborates effectively across functions and organizational boundaries.
• Communicates clearly with both technical and non-technical stakeholders.
• Proactively seeks relevant stakeholder input and expertise to support effective decision-making.
• Takes ownership and accountability for decisions, actions, successes, and challenges.
• Demonstrates strong planning and organizational skills, effectively managing priorities, resources, and timelines.
• Maintains a strong focus on quality, compliance, and timely execution.
• Demonstrates a proactive approach to identifying risks, resolving issues, and driving continuous improvement.
• Supports and coaches colleagues by sharing technical knowledge and best practices.

Knowledge & Experience

• 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.
• Experience in one or more of the following therapeutic areas is preferred: Oncology, Rare Disease, or Neuroscience.

Knowledge & Experience (preferred)

• R or other packages are desired;
• Understand clinical data flow. Experience in NDA/sNDA submission is desired.

Education / Certifications (essential)

• Bachelor or MSc in Statistics, Mathematics, or Scientific Discipline

Language(s) (essential)

• English

Language(s) (preferred)

• French