Associate Director, Biostatistics – Hematology

This position is for a qualified statistician/biostatistician to support Clinical Biostatistics with Global Development.

The incumbent will lead efforts of the Biostatistics department 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 represent statistical issues in regulatory agency meetings.

The incumbent will lead the development and delivery of training to non-statistical colleagues, lead the development of new infrastructure and processes, and be active in representing the company in professional associations, conferences, and publications. As an Associate Director, the incumbent will be responsible for mentoring and overseeing less experienced statisticians, with the potential to manage full-time staff.

• Represent Biostatistics at Global Clinical sub-teams.

• Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.

• Lead contributions to the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for advisory committee meetings, etc.

• Lead and contributes to process improvement and technical working groups and sets timelines and expectations for the deliverables. Authors new/revised SOPs and contributes to cross-functional EPIC work streams.

• Evaluate appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools.

• 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 with >6 years of experience in the pharmaceutical industry OR MS degree in statistics/biostatistics with >11 years of experience

• Preferred:
  Hematology, IO, non‑oncology, Multiple Myeloma experience or similar Therapeutic Area.

• Time to Event (TTE) experience.

• Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies.

• 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

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!

For additional information about Regeneron benefits in the US, please visit  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on‑site…