Associate Director, Biostatistics - Genetic Medicine
Regeneron
1 month ago
On-site
Tarrytown, NY
Clinical Research and Development
Role Responsibilities:
- Lead biostatistics efforts with cross-functional teams to articulate drug development questions, assess feasibility of endpoints, frame statistical approaches, and design clinical experiments/interventional studies.
- Work with teams to interpret results and make decisions.
- Represent statistical issues in regulatory agency meetings.
- Lead development and delivery of training to non-statistical colleagues.
- Lead development of new infrastructure and processes.
- Represent the company in professional associations, conferences, and publications.
- As Associate Director: mentor and oversee less experienced statisticians; potential to manage full-time staff.
Role “This Role Might Be For You If Can”:
- 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.
- Draft analysis plans; review TFLs for regulatory meetings; contribute to advisory committee slide materials.
- Lead/contribute to process improvement, technical working groups, and SOP updates; support cross-functional EPIC workstreams.
- Evaluate appropriateness of software for planned analyses; determine need for novel statistical methodology/tools.
- Prepare presentations and written reports for project team, management, and regulatory agencies; co-present to management.
- Participate in research on innovative statistical methods and provide training to non-statisticians.
Qualifications:
- PhD or equivalent in statistics/biostatistics with >6 years pharmaceutical industry experience OR MS in statistics/biostatistics with >11 years.
- Preferred: Hematology, IO, non-oncology, Multiple Myeloma experience or similar therapeutic area.
- Time to Event (TTE) experience.
- Knowledge of drug discovery and development; ability to integrate statistical concepts into development strategies.
- Excellent influence/leadership; demonstrated cross-functional collaboration.
- Ability to work in a fast-paced collaborative environment; critical thinking, time management, effective communication.
- Solid knowledge of statistical analysis methodologies, experimental and clinical trial design.
- Expertise in statistical software.
Benefits (if explicitly stated):
- US benefits may include health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves.
Application Instructions:
- “Does this sound like you? Apply now to take your first step towards living the Regeneron Way!”
- Lead biostatistics efforts with cross-functional teams to articulate drug development questions, assess feasibility of endpoints, frame statistical approaches, and design clinical experiments/interventional studies.
- Work with teams to interpret results and make decisions.
- Represent statistical issues in regulatory agency meetings.
- Lead development and delivery of training to non-statistical colleagues.
- Lead development of new infrastructure and processes.
- Represent the company in professional associations, conferences, and publications.
- As Associate Director: mentor and oversee less experienced statisticians; potential to manage full-time staff.
Role “This Role Might Be For You If Can”:
- 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.
- Draft analysis plans; review TFLs for regulatory meetings; contribute to advisory committee slide materials.
- Lead/contribute to process improvement, technical working groups, and SOP updates; support cross-functional EPIC workstreams.
- Evaluate appropriateness of software for planned analyses; determine need for novel statistical methodology/tools.
- Prepare presentations and written reports for project team, management, and regulatory agencies; co-present to management.
- Participate in research on innovative statistical methods and provide training to non-statisticians.
Qualifications:
- PhD or equivalent in statistics/biostatistics with >6 years pharmaceutical industry experience OR MS in statistics/biostatistics with >11 years.
- Preferred: Hematology, IO, non-oncology, Multiple Myeloma experience or similar therapeutic area.
- Time to Event (TTE) experience.
- Knowledge of drug discovery and development; ability to integrate statistical concepts into development strategies.
- Excellent influence/leadership; demonstrated cross-functional collaboration.
- Ability to work in a fast-paced collaborative environment; critical thinking, time management, effective communication.
- Solid knowledge of statistical analysis methodologies, experimental and clinical trial design.
- Expertise in statistical software.
Benefits (if explicitly stated):
- US benefits may include health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves.
Application Instructions:
- “Does this sound like you? Apply now to take your first step towards living the Regeneron Way!”