Senior/Principle Biostatistician - Immunology/Inflammation/Ophth

Tarrytown, New York
Mar 20, 2018
Required Education
Masters Degree/MBA
Position Type
Full time
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.

The Biostatistics group that supports the Immunology/Inflammation/Ophthalmology Therapeutic Focus Area Is looking for a Principal Biostatistician with MS or PhD Biostatistics/Statistical curriculum to join our Biostats & Data Mgmt department (BDM). The position assumes responsibility for methodological and statistical aspects of a project or group of clinical studies, with general direction from Therapeutic Area lead biostatistician. Basic understanding of key clinical and regulatory concepts, endpoints, and trial designs in one or more therapeutic areas / indications is required. In some cases incumbent could serve as technical support in a particular statistical area or application.

• Act as direct liaison to the study team or provide guidance to a junior staff member filling this role.
• Provide leadership in development / design of one or more protocols for a specific project and support/participate in the development of clinical program
• Develop statistical analysis plan (SAP), programming specifications, and SAS programing for derived dataset and validate TFLs
• Provide guidance, either personally or through a junior member of the statistical team, on definition and documentation of derived variables needed to produce planned TFL. Assume responsibility for accuracy of derived variables
• Perform inferential analyses; inputs to the statistical section of the clinical study report (CSR) and review clinical study report. Provide support for the study team to move CSR through the review and approval process. Provide statistical insight into interpretation and discussion of study results.
• With periodic supervision and guidance to perform relevant sample size calculations and other supports on all relevant statistical matters
• Collaborate with project team on the production of the clinical development plan (CDP) and May act as representative to extended project team
• Must have the ability to generate all of the production statistical output and hands on experience with SAS, S-Plus (or R), other software related statistical work
• Produce / coordinate production of statistical summaries, analyses, annual reports, and publication review, preparation of scientific research related materials
• Extensive leadership skills and extensive outsourcing project managing experience with CROs.

• Ph.D. (MS) in statistics or related discipline with 3+ (5+) years of experience in the biotechnology, pharmaceutical or health related industry.
• Solid skills in applying statistical concepts and knowledge.
• Good written and oral communications skills strongly preferred
• Ability to work in fast-paced environment is required

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.

Requisition Number: 10401BR