Principal Statistician

Overview Principal Statistician – lead statistical strategy for global projects in Ipsen development portfolio. Location: Paris, France / Paddington, UK. Responsibilities Statistical adviser to global project teams, providing input for project development and contributing to statistical work for other projects as required. Collaborate with Early/Medical Development Director and other groups to deliver high‑quality, timely, robust statistical input for clinical development plans. Ensure statistical review and approval of study protocols and other relevant documents (Data Handling Plan, Randomisation Plan, SAP, TLF Shell, Clinical Study Report) meets objective, rigorous standards. Lead project and study‑level activities, supporting external vendor statisticians. Provide statistical input for selection, evaluation and oversight of external vendors, ensuring deliverables meet project specifications, quality, content and timetable standards. Coordinate regulatory statistical activities, presenting methods to regulatory bodies (FDA, EMA, national bodies) and managing the regulatory review process. Plan, schedule and track all statistical activities to guarantee high‑quality, timely, accurate completion of deliverables. Work closely with Data Management staff to support integrated quality databases for regulatory review. Increase awareness of statistical rigor across Ipsen R&D groups by collaborating with other statisticians (Modelling and Simulation) and staying current on statistical theory and application. Maintain compliance with R&D SOPs and other Ipsen Group documentation. EHS Responsibilities Comply with applicable EHS regulations and procedures. Report risks, malfunctions or improvement opportunities. Participate in mandatory EHS training. Behavioural Competencies Ensures accountability for tasks and outcomes. Builds an environment where clarification is sought when accountability is unclear. Consults relevant stakeholder views, coaches decisions, and seeks consent vs. consensus. Takes personal accountability for decisions, actions and outcomes. Follows through on commitment and encourages others to do the same. Manages complexity by identifying contradictory information and developing alternative scenarios. Communicates effectively, asking open questions, respecting different perspectives, and using visual communication and storytelling to convey clear, focussed messages. Knowledge & Experience (essential) 3‑6 years’ experience in a similar position. Advanced knowledge of statistics and the drug development process applied to clinical studies. High knowledge of international standards (ICH, GCP, CDISC) and regulatory submission experience (FDA, EMA, etc.). Proficiency with statistical software tools such as SAS, R, S‑Plus, EAST, JMPC, etc. Expertise in oversight and management of external vendors. Project management skills: planning, risk mitigation, status reporting and metric communication with external vendors and internal partners. Ability to produce high‑quality, accurate work to meet deadlines. Excellent time management, communication, presentation, analytical and interpersonal skills. Education / Certifications (essential) MS in Statistics or Biostatistics. Education / Certifications (preferred) PhD in Statistics or Biostatistics. Language(s) (essential) Fluent in English (verbal and written). #J-18808-Ljbffr