Associate Director, Biostatistics
The AD, Biostatistics is responsible for working with study team members to design late stage protocols, develop and write statistical analysis plans, and perform statistical analyses for interim and final reports to be submitted to regulatory agencies. The Senior Manager will also support submission activities, including review of clinical summaries and writing responses to regulatory questions. Project level activities will include organization and scheduling of DMC reports, semi-annual safety reporting to regulatory agencies, and developing processes to provide AE information to adjudication committees. Attendance and statistical contributions at study team and project team meetings are expected. Within the BDM Department, leadership skills are needed to organize and schedule deliverables among the statisticians, SAS programmers and data managers. All BDM members are expected to support department infrastructure projects on an annual basis, including SOP improvement, development of white papers for innovative statistical methodology, new software user testing and support, etc… Mentoring opportunities are also available.
The following educational and previous clinical trial experience are required for this position:
- PhD in Statistics or Biostatistics
- 7+ years clinical trial experience in either a biotechnology or pharmaceutical company
- Hands-on Phase IIb/III clinical trial experience and proficient in SAS programming
- Excellent oral and written communication skills, and proficient in presenting power point presentations.
- Although not required, previous support of regulatory submissions in the US, Europe, Canada, or Japan.
- Although not required, previous clinical trial experience in the therapeutic areas of oncology
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Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #LI-S