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 (R) (aflibercept) Injection, ZALTRAP (R) (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST (R) (rilonacept) Injection for Subcutaneous Use. Regeneron has filed a regulatory application with the U.S. Food and Drug Administration (FDA) for a second indication for EYLEA. 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.
The Manager/Sr. Manager, Biostatistics will work on the projects/studies in Oncology therapeutic area and assume responsibility for statistical aspects of a project or group of clinical studies, with general direction from Therapeutic Area lead biostatistician. Provide leadership and guidance on statistical matters to interdepartmental clinical / regulatory teams. In some cases the incumbent could serve as a technical expert in a particular statistical area or application. Actual title for the position will be determined based on skills and experience
The Key responsibilities:
• Provide leadership and statistical support to one or more study teams on all relevant statistical matters including study design, defining the study endpoints, determine methods of statistical analysis, etc.
• Development the statistical analysis plan (SAP), oversee the execution of the statistical analysis according to the SAP and preparation of the statistical methods and results sections for the clinical study report (CSR). 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 to independent monitoring committees. Review submission documents, such as IND, BLA, or CTD to insure statistical validity and accuracy.
• Collaborate with project team on the production of the clinical development plan (CDP). Work with senior departmental staff to develop statistical position on key study or project issues. May act as representative to the extended project team.
• Provide significant input to Therapeutic Area lead biostatistician on project activity and timeline tracking, resource planning, and preparation of scientific reports or position papers.
• Contribute to the departmental projects, such as the development of SOPs and BDM standards.
• Ph.D in statistics or related field
• 5 + year experience in pharmaceutical /biotech industry
• Strong hands-on experience with clinical trial and clinical development
• Good working experience in oncology therapeutic area
• Expertise and some practical experience in some advanced statistical methodologies, especially with application to clinical trial design and analysis
• Working knowledge of regulatory guidelines for drug development, BLA submissions, and statistical practices, e.g., CTD guidance and ICH guidelines
• Ability to use statistical methods to assess/improve efficiency and effectiveness in drug development
• Self-directed and comfortable working in teams with the ability to work and operate independently within a tight deadline environment. High degree of creativity, latitude and attention to detail required.
• Strong organizational and communication skills, experiences in working with clinical/project team
• Good knowledge of SAS, R and sample size calculation software.
• Proficiency with MS Office applications
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.
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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