Associate Director, Biostatistics - Genetic Medicine

Statistician/Biostatistician

This position is for a qualified statistician/biostatistician to support Clinical Biostatistics with Global Development.

In this role, a typical day might include:

• Leading 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.
• Representing statistical issues in regulatory agency meetings.
• Leading the development and delivery of training to non-statistical colleagues, leading the development of new infrastructure and processes, and being active in representing the company in professional associations, conferences, and publications.
• As an Associate Director, 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:

• 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 contribute to process improvement and technical working groups and set timelines and expectations for the deliverables. Author new/revised SOPs and contribute to cross-functional EPIC workstreams.
• Evaluate appropriateness of available software for planned analyses and determine 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-present findings to management.
• Be involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians.

To be considered for this opportunity, you must have the following:

• 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.
• Ability 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.