Regeneron is currently seeking a talented and motivated Biostatistics Consultant to join our Biostats & Data Mgmt department. This position is responsible for implementing and executing methodological and statistical aspects of clinical studies with direction from Therapeutic Area lead biostatistician or project lead statistician. Provide leadership and guidance on statistical matters to interdepartmental clinical / regulatory teams. Principal function may also include developing / employing technical expertise in a particular statistical area or application.
- Support/participate in the development of clinical program
- Review protocols and CRFs for soundness of trial design
- Write statistical methodology section of the protocol
- Develop statistical analysis plan (SAP), programming specifications, and SAS programing for derived dataset and validate TFLs
- Perform inferential analyses; inputs to the statistical section of the clinical study report and review clinical study report
- Support/participate in project related activities including preparation of BLA submissions and oversee CR0 deliverables for studies contracted out
- With periodic supervision and guidance from senior departmental staff, provide support and leadership to a clinical study team on all relevant statistical matters
- Act as liaison to study team, ensuring that the clinical study is conducted in a manner that supports planned statistical analysis.
- With some supervision and guidance from senior departmental staff, design clinical study and help produce protocol or amendments.
- Perform relevant sample size calculations
- Work with programming team to provide definitions, documentation, and review of derived variables needed to produce planned TFL
- Perform statistical analysis defined in SAP, prepare statistical methods and results sections for the clinical study report (CSR), and work with the study team to move the CSR through review and approval process
- Provide statistical insight into interpretation and discussion of study results
- Produce / coordinate production of statistical summaries, analyses, annual reports, and related materials for submission to regulatory authorities or independent monitoring committees
- Provide assistance to project biostatistician or Therapeutic Area lead biostatistician in project activity and timeline tracking, resource planning, and preparation of scientific reports or position papers.
- PhD and/or MS in biostatistics or statistics
- 5+ years of biopharmaceutical experience
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.