If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.
Regeneron is currently seeking a talented and motivated student with MS or PhD Biostatistics/Statistics curriculum to join our Biostatistics & Data Management department (BDM). The position assumes responsibility for statistical aspects of clinical studies under the supervision of the Therapeutic Area lead biostatistician. Basic understanding of key clinical and regulatory concepts, endpoints, and trial designs is required. In some cases incumbent could serve as technical support in a particular statistical area or application.
• 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. Review case report form (CRF) and provide comments and feedback.
• Under supervision and guidance of senior departmental staff, develop statistical analysis plan (SAP).
• Provide programming team with definitions and documentation for derived variables needed to produce planned Tables/Figures/Listings (TFLs). Develop data and programming specifications jointly with study 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), and work with the study team to move the CSR through review /approval process.
• Perform statistical activities supporting clinical trial randomization, e.g., working with clinical trial managers, clinical drug supply liaison, specification of randomization schemes, and completion of request form.
• With periodic supervision and guidance to perform relevant sample size calculations and other supports on all relevant statistical matters.
• Must have the ability to generate all of the production statistical output and hands on experience with SAS, S-Plus (or R), and other software related statistical work.
• Coordinate and work on the production of statistical summaries, analyses, annual reports, and publication review, preparation of scientific research related materials.
• MS in statistics with 3+ years of experience or PhD in biostatistics, statistics, mathematics or related fields with 0+ years of experience in the biotechnology and pharmaceutical industry.
• Solid skills in applying statistical concepts and knowledge.
• Ability to program basic data presentations and common statistical analyses.
• Ability to meet tight timelines for deliverables such as key results and final analyses.
• Ability to work with internal teams and manage CROs
• Good written and oral communications skills strongly preferred
• Ability to work in fast-paced environment is required
We offer a competitive compensation and benefits package including stock incentives, 401k with company match as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.
Disclaimer: Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. 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 without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means. Moving forward, Regeneron is using the agency management company, Candex - www.candex.com
ARCALYST, EYLEA, and ZALTRAP are trademarks of Regeneron Pharmaceuticals, Inc.
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