Regeneron Pharmaceuticals, Inc.
Basking Ridge, New Jersey, United States
Job type: fulltime
Job industry: Science & Technology
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 and Data Management group is looking for a Biostatistician to support Clinical Development and Exploratory Sciences. This position is for a qualified statistician with experience in the pharmaceutical/biotechnology sector, to collaborate in cross-functional drug development teams to develop and execute innovative statistics for the development of strategy and analysis of clinical trial studies.
Known for its scientific and operational excellence, Regeneron is a leading science-driven 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 incumbent will work with cross-functional teams to articulate drug development questions, frame statistical approaches to address those questions, and analyze the resulting data, primarily focused on supporting development strategy and analysis across therapeutic areas covering multiple pipelines within the company. The incumbent will provide his/her statistical expertise to conduct statistical analysis on multiple assigned projects, develop innovative statistics methodologies or clinical trial designs for drug discovery, present at management and team meetings, co-author publications and influence the external pharmaceutical industry and regulatory environment through participation in professional associations, conferences, and publications.
Responsible for facilitating career development of direct reports and assisting VP, BDM and/or Sr. Director, Biostatistics, with creation and implementation of policies. May have management responsibility. In some cases incumbent could serve as department leader in specific technical area.
With minimal direction from departmental management, assume leadership role for providing statistical support to one or more project teams in the creation of a clinical development plan (CDP), study designs, and production of individual protocols. Work with other BDM members or consultants to develop effective statistical approaches applicable to project. Produce or review individual statistical analysis plan (SAP) and planned integrated summaries.
Interact with the clinical / regulatory functions to define study endpoints and perform relevant sample size calculations. Learn key clinical and regulatory considerations, ensure that planned statistical methods are applicable, and communicate important statistical considerations to clients.
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. Effect consistency of data collection and analysis within project.
Oversee production of the statistical analyses according to SAP. Oversee preparation of the statistical methods and results sections for CSR and overall summaries. Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package. Serve as company statistical representative at regulatory or external meetings.
Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization.
Provide technical direction and mentoring to staff. Maintain awareness of industry standards and regulatory requirements and communicate within team. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation.
This position requires a minimum of a PhD or equivalent degree in statistics/biostatistics or related disciplines with a minimum 4-5 years of experience. Entry level candidate with outstanding academic record will also be considered, at the Sr biostatistician level, more experienced candidates at the Principal level (Level will be commensurate with experience.).
• Solid knowledge of statistical analysis methodologies and computational statistics. The ideal candidate will have a strong background in Bayesian methodology, MCMC techniques, statistical computing, data mining, machine learning, modeling and simulation, linear and nonlinear models, and model-informed drug development
• Expertise in statistical software such as R, SAS, WinBUGS, JAGS is required. Familiarity with STAN, R -Shiny, C++ and high performance scientific computing will be a plus.
• Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies.
• Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, and effective communication and presentation skills.
• Excellent influence and leadership skills, with a track record of collaboration with scientists and researchers at Biostatistician level.
• Publications in peer reviewed statistical/medical journals
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, Biostatistics, biostats, statistics,