Regulatory Affairs jobs in Germany
Sr-Principal Biostatistician - Medical Affairs (Europe and LATAM ONLY)
Syneos Health, Inc.
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Medella Life
Sr-Principal Biostatistician - Medical Affairs (Europe and LATAM ONLY)
Job summary
A leading biopharmaceutical solutions organization in Munich is seeking a Sr-Principal Biostatistician to lead biostatistical initiatives in medical affairs. The candidate will manage diabetes and cardiovascular projects, develop analysis plans, and support the lifecycle of clinical studies. A PhD in Biostatistics or a related field and extensive experience in statistical programming are required. This role involves collaboration with various departments and may require travel. Join us in making a difference in clinical development.
Qualifications
- PhD in Biostatistics or a related discipline required.
- Extensive experience in biostatistical leadership and statistical programming.
- Excellent project management and communication skills.
Responsibilities
- Lead biostatistical efforts on diabetes and cardiovascular projects.
- Develop Statistical Analysis Plans and coordinate project activities.
- Review programming specifications and ensure quality control.
Skills
Education
Tools
Description
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates innovation in clinical development. This role focuses on biostatistical leadership for medical affairs projects in Europe and Latin America.
Our Clinical Development model places the customer and the patient at the center of everything we do. We work to simplify and streamline our work to make Syneos Health a great place to work.
Job Responsibilities
- Work on two projects in diabetes and cardiovascular therapeutic areas.
- Develop and execute methods for external control arm analyses and time‑to‑event analysis.
- Provide support across the lifecycle of the project, from protocol development to the Clinical Study Report.
- Prepare Statistical Analysis Plans (SAPs) and mock‑up displays for tables, listings, and figures.
- Coordinate activities of biostatistics and statistical programming staff, ensuring timely delivery of high‑quality work.
- Review programming specifications for analysis datasets, tables, listings, and figures.
- Review SAS‑annotated CRFs, database designs, and other study documentation to verify protocol criteria.
- Participate in verification and quality control of project deliverables.
- Implement alternative solutions to address business and operational challenges.
- Represent biostatistics on project teams, interfacing with other departmental representatives.
- Manage scheduling and time constraints across multiple projects, communicating proactively with biostatistics management.
- Monitor progress against milestones and identify out‑of‑scope tasks.
- Provide statistical programming support as needed.
- May participate in Data Safety Monitoring Board or Data Monitoring Committee activities.
- May lead integrated analyses, attend regulatory agency meetings, or respond to questions.
- Follow applicable SOPs, WIs, and regulatory guidelines (e.g. ICH).
- Maintain well‑organized and up‑to‑date project documentation and verification/quality control records.
- Support business development activities by contributing to proposals, budgets, and sponsor bid defense meetings.
- Coach and mentor other biostatistics staff.
- Perform other work‑related duties as assigned.
- Travel may be required.
Additional Information
Tasks, duties, and responsibilities listed in this job description are not exhaustive. The Company may assign other tasks or duties with no prior notice. Equivalent experience, skills, and/or education may be considered. The Company complies with relevant legislation, including the EU Equality Directive and the Americans with Disabilities Act, and offers reasonable accommodations as needed.
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* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.