Manager, Biostatistics

Location
Basking Ridge, NJ, United States
Posted
Oct 16, 2020
Ref
21296BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

In this role a typical day may include the following:
  • With supervision and mentorship from senior departmental staff, provide support to a clinical study team and strategic project team on all relevant statistical matters. Working directly with the medical directors and study personnel, act as liaison to study team, ensuring that the clinical study is conducted in a manner that supports planned statistical analysis. Defend design at management forums (DPR and PRC).
  • With supervision and mentorship from senior departmental staff, contribute to design of a clinical study and help draft protocols or amendments. Perform sample size calculations.
  • Develop statistical analysis plan (SAP). Perform analyses and author statistical methods and results sections of the clinical study report (CSR). Provide statistical insight into interpretation and discussion of study results. Contributes tables and figures for management presentations.
  • Under limited supervision and mentorship of experienced statisticians, contributes to clinical trial teams. Attends GCST and SPT on programs to represent department.
  • Independently prepares TFLs to support CSRs, DSURs, IB and documents. Collaborates with Medical Writing and Clinical to ensure tables are complete. Supports TFL production for ISE/ISS for submissions. Contributes to regulatory submissions.
  • Under mentorship of senior staff, supports preparation of material to be used in regulatory interactions, including drafting analysis plan under supervision/mentorship and production of TFLs to be used in regulatory meetings, slides for ACMs, etc.
  • Supplies to authoring of regulatory background packages, including those for pre-IND, EOP2, and pre-BLA meetings. Will give background material for ACMs and perform additional analyses as required for labeling negotiations. Attends pre-IND, EOP2, and pre-BLA meetings with experienced statistician.
  • Supplies to working groups by developing new methodology and conducting simulation studies under the supervision of senior departmental staff. Supplies to revising SOPs.
This role may be for you if:

You have a PhD or equivalent degree in statistics/biostatistics or related subject areas with >2 years work experience, OR MS with >3 years work experience at Sr Biostatistician level.
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.