Associate Director, Biostatistics & Regulatory Strategy

BioSpace; Village of Tarrytown (NY); On-site; USD 176,000 - 287,000; Full time

Job summary

Regeneron is seeking an Associate Director to lead the Biostatistics team and collaborate with Global Clinical sub-teams to shape analytic plans for complex trials. You will mentor statisticians, develop infrastructure, and represent statistics in regulatory discussions.

You will drive training for non-statisticians, oversee SOPs, and contribute to EPIC initiatives while advancing innovative methods in drug development. On-site work in NY/NJ region preferred.

Qualifications

• PhD or equivalent in statistics/biostatistics with >6 years in the pharmaceutical industry OR MS 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

Responsibilities

• 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 workstreams.
• 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.

Skills

Biostatistics

Leadership

Cross-functional collaboration

Regulatory liaison

Statistical software

Mentoring

Education

PhD in statistics/biostatistics

MS in statistics/biostatistics

Tools

SAS

R

Job description

Regeneron is seeking an Associate Director to lead the Biostatistics team and collaborate with Global Clinical sub-teams to shape analytic plans for complex trials. You will mentor statisticians, develop infrastructure, and represent statistics in regulatory discussions.

You will drive training for non-statisticians, oversee SOPs, and contribute to EPIC initiatives while advancing innovative methods in drug development. On-site work in NY/NJ region preferred.