Director, Biostatistics, Late Development CV/Metabolism
The Biostatistics and Data Management Department seeks a Director of Biostatistics to lead a clinical program and provide statistical expertise to the global clinical project team. The position will contribute to 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 safety information to adjudication committees. Attendance and statistical contributions at project team meetings are expected. Within the BDM Department, leadership skills are needed to organize and schedule project level 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, etc.
This job may be for you if you have the following background and experience:
- Ph.D. in Statistics or related discipline with 10+ years of experience in either the biotechnology or pharmaceutical industry.
- Provided statistical support to multiple indications across program teams. Collaborated with clinical and regulatory leads in defining general strategic approaches, creating clinical development plans (CDP), and producing individual protocols.
- Developed effective statistical approaches applicable to project, and oversee execution and reporting of statistical analysis results in clinical study reports (CSR).
- Provided guidance to the clinical and regulatory teams regarding interpretation of integrated analysis results, and supported regulatory interactions.
- Planned and tracked project activities, timelines, and resource use. Mentored and developed staff.
- Excellent verbal, written, & presentation skills.
- Applied awareness of industry standards, regulatory requirements, and departmental guidelines and SOP to study/project work.
- 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 cardiovascular and metabolism.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
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-SC1