Senior/Principal Statistical Programmer

This is a fully remote position, open to applicants in Europe.

📋 Description

• Act as the primary statistical programmer for various studies and/or compounds.

• Manage and implement statistical programming tasks from the initiation of the study to database lock, reporting, and regulatory submissions.

• Ensure the quality, consistency, and timely completion of programming deliverables.

• Assist with global regulatory submissions and address inquiries from health authorities.

• Provide technical oversight and direction for outsourced statistical programming efforts.

• Create, review, and validate tables, listings, figures, SDTM/ADaM datasets, and Define-XML documentation.

• Write SAS programs, conduct quality control/validation, and document statistical programming processes.

• Contribute to the development of SAS programming standards, standard operating procedures (SOPs), work instructions, and best practices.

• Keep study programming documentation in compliance with Ipsen processes, ensuring it is ready for inspection/audit.

• Collaborate effectively with statisticians, clinical teams, data management, and other cross-functional stakeholders.

• Offer technical guidance and mentorship to fellow statistical programmers.

• Identify opportunities for process improvements and support complex study design methodologies.

• Serve as a subject matter expert in statistical programming and contribute to technical decision-making.

⛳️ Requirements

• Extensive proficiency in SAS programming within a pharmaceutical, biotechnology, or CRO setting.

• Strong comprehension of CDISC standards, including SDTM and ADaM.

• Practical experience with SDTM and ADaM specifications, development, and programming.

• Significant experience in TFL programming and reporting.

• Background in supporting clinical trial reporting and/or regulatory submissions.

• Experience handling complex clinical trial data and study designs.

• Capability to provide technical leadership and independently oversee programming tasks across multiple studies.

• Over 8 years of statistical programming experience in a pharmaceutical, biotechnology, or CRO environment focused on clinical development.

• Bachelor's or Master's degree in Statistics, Mathematics, or a related scientific discipline.

• Proficiency in English is required.

• Experience in Oncology, Rare Disease, or Neuroscience is preferred.

• Knowledge of R or other statistical packages is desirable.

• Experience with NDA/sNDA submissions is a plus.

• Proficiency in French is preferred.

🏝️ Benefits

• Job security and additional career advancement opportunities within a global CRO.

• Ongoing training and professional development opportunities.

• Close management support and training.

• Commitment to equal opportunity and diversity/inclusivity.