Biostatistician (Consultant) 1 of 2

Location
Basking Ridge, New Jersey, US
Posted
Sep 10, 2018
Ref
13275BR
Required Education
Doctorate/PHD/MD
Position Type
Contract
Position Summary

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.

Summary
The Biostatistician implements and executes methodological and statistical aspects of clinical studies under the supervision of Therapeutic Area lead biostatistician or project lead statistician. In some cases principal function could be to develop/employ technical expertise in a particular statistical area or application.

Responsibilities

• Under direct supervision and guidance of senior departmental staff, provide support to a clinical study team on all relevant statistical matters. As member of study team, ensure the clinical study is conducted in a manner that supports planned statistical analysis.

• Under supervision and guidance of senior departmental staff, participate in preparation of study protocol and amendments. Perform relevant sample size calculations and write statistical methodology section of the protocol.

• Review case report form (CRF) and provide comments and feedback.

• Develop statistical analysis plan (SAP).

• Provide programming team with definitions and documentation for derived variables needed to produce planned Tables, Figures and Listings (TFLs). Develop data and programming specifications jointly with programmers.

• Perform statistical analysis according to the SAP, validate analysis programs, review TFLs, prepare statistical methods and results sections for the clinical study report (CSR), provide statistical insight into interpretation and discussion of study results, and work with the study team to move the CSR through review /approval process.

• Support/participate in project related activities including preparation of BLA submissions and oversee CRO deliverables for studies contracted out

Requirements
A PhD and at least 2 years of biopharmaceutical experience is required.

Level will be commensurate with experience.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

LMR, #LI-LR1, Biostatistician, statistician