Associate Director, Biostatistics - Immunology

Regeneron Pharmaceuticals • Warren, MI

15d

About The Position

In this role, a typical day might include: 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. This role might be for you if you can/have: Represents Biostatistics at strategic program teams and Global Clinical Subteams and serves as program statistician leading one or more programs in immunology. Interacts with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials. Leads 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. Leads 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 workstreams. Evaluates appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools. Prepares 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.

Requirements

• PhD or equivalent degree in statistics/biostatistics with >6 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >11 years’ 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 such as R or SAS is required

Responsibilities

• Represents Biostatistics at strategic program teams and Global Clinical Subteams and serves as program statistician leading one or more programs in immunology.
• Interacts with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.
• Leads 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.
• Leads 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 workstreams.
• Evaluates appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools.
• Prepares 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.

Benefits

• 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
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree