Principal Biostatistician - Oncology

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Principal Biostatistician to join our Global Development team.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

• Work Location:
  
  Sleepy Hollow, NY or Warren, NJ
• 4 days per week on site
• 25% Travel may be required

The incumbent will work with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. The incumbent will co-author clinical study protocols, statistical analysis plans, and perform statistical analyses for interim and final reports.

The incumbent will also develop and deliver training to non-statistical colleagues, collaborate on development of new infrastructure and processes, and influence the external pharmaceutical industry and regulatory environment through participation in professional associations, conferences, and publications.

• Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.
• Develop individual protocols and statistical analysis plans and determines appropriate statistical methodology for data analysis.
• Collaborate with Statistical Programming on the programming of tables, figures and listings to support decision making and for regulatory reporting.
• Evaluate appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools.
• Analyze data and interprets results from clinical trials and of data from non-trial sources to facilitate program-level decision making.
• Prepare presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies. Co-presents findings to management.
• Is involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians.

• PhD or equivalent degree in statistics/biostatistics or related disciplines with internship experience, or MS degree in statistics/biostatistics with >5 years’ experience in the pharmaceutical industry as a statistician.
• Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment.
• Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills.
• Solid knowledge of statistical analysis methodologies, experimental and clinical trial design
• Expertise in statistical software such as R or SAS is required

Does this sound like you?

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic…