Associate Director, Biostatistics - Genetic Medicine

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 plans, reviewing TFLs for regulatory meetings, and preparing slides for advisory committee meetings.
• Lead and contribute to process improvement and technical working groups, set timelines and expectations for deliverables, author new or revised SOPs, and contribute to cross‑functional EPIC work streams.
• Evaluate appropriateness of available software for planned analyses and determine needs for novel statistical methodology or tools.
• Prepare presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies. Co‑present findings to management.
• Conduct research activities for innovative statistical methods and applications in clinical trial development and provide 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.

Salary Range (annually): $ – $

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.