Associate Director, Biostatistics - Genetic Medicine

Job Overview

Qualified statistician/biostatistician to support Clinical Biostatistics with Global Development.

• Lead efforts of the Biostatistics department with cross‑functional teams to articulate drug development questions, assess feasibility of endpoints, and frame statistical approaches to address those questions.
• Design clinical experiments and interventional studies, generate and analyze resulting data, and work with teams to interpret results and support decision‑making.
• Represent statistical issues in regulatory agency meetings.
• Lead development and delivery of training to non‑statistical colleagues, and develop new infrastructure and processes.
• Represent the company in professional associations, conferences, and publications.
• Mentor and oversee less experienced statisticians, with potential to manage full‑time staff.
• Represent Biostatistics at Global Clinical sub‑teams and interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.
• Prepare material for regulatory interactions, including drafting analysis plans, reviewing Trial Facilitation Letters (TFLs), and slides for advisory committee meetings.
• Lead and contribute to process improvement and technical working groups, setting timelines and expectations for deliverables.
• Author new or revised Standard Operating Procedures and contribute to cross‑functional EPIC work streams.
• Evaluate suitability of software for planned analyses and determine needs for novel statistical methodology or tools.
• Prepare presentations and written reports to communicate results to project teams, management, and regulatory agencies; co‑present findings to management.
• Conduct research on 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 with >11 years of experience.
• Preferred: experience in Hematology, IO, non‑oncology, Multiple Myeloma, 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 demonstrated ability to collaborate in a cross‑functional environment.
• Ability to work productively in a fast‑paced collaborative environment, with critical thinking, time‑management, and effective communication skills.
• Solid knowledge of statistical analysis methodologies, experimental and clinical trial design.
• Expertise in statistical software.

Benefits vary by location and may include health and wellness programs (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 leave (e.g., military and parental leave) for eligible employees at all levels.

Salary (Annually): $ - $ (U.S. positions).

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, 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.

Regeneron will also provide reasonable accommodation for qualified applicants with disabilities.

Background checks will be conducted in accordance with the law of the country where the position is based, to verify identity, right to work, educational qualifications, etc.