• Act as the responsible statistician for international development projects. Participate in project teams in the role of a Project Statistician (PSTAT) to collaborate with the Clinical Program Lead in developing the clinical development plan, prepare the project statistical analysis plan, and participate in the writing of the integrated summary documents for worldwide submissions and of publications thereof.
• Take on the key statistical responsibility in the planning and preparation of regulatory submissions as required. Lead and mentor other statisticians within a project.
• Act as PSTAT-Medical Affairs (PSTAT-MA) for key marketed products. Support other project team members from Medical Affairs, Pharmacovigilance and MAPOR.
• Act as TSTAT for critical, complex clinical trials such as mega-trials.
• Mentor other statisticians and provide consultancy and expert advice in case of critical or complex statistical-methodological issues and promote innovative statistical methods at BI.
• M.S. in statistics, biostatistics, or biometry with 8+ years or Ph.D. in statistics, biostatistics, or biometry with 4+ years of initial experience as statistician.
• Ability to interact with authorities and external bodies (specialists and non-specialists) on statistical-methodological issues for pivotal trials or complex projects.
• Ability to successfully plan and conduct a submission project.
• Ability to challenge methodological issues.
• Ability to supervise scientific/technical work.
• Excellent interpersonal skills, ability to interact effectively with people, internally and externally.
• Excellent oral and written communication and presentation skills.
• Evidence of strong trial teamwork.
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheimis an equal opportunity employer.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers.