Job Abstract

Director, Biostatistics Early Clinical Development Gene Therapy 

The Director of Biostatistics provides leadership and guidance as the statistical expert on a project team or within a therapeutic area.

In this role, a typical day might include:

This position is for a qualified statistician/biostatistician to support Clinical Biostatistics within Global Development.  The incumbent will lead and/or oversee the 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 work with Strategic Project Teams on clinical and regulatory strategies for clinical development, and to 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 a Director, the incumbent will be responsible for mentoring and overseeing less experienced statisticians and work with those statisticians to ensure other programs are properly supported, with the potential to manage full-time staff. 

This role might be for you if you can:

• Represents Biostatistics at Global Clinical Subteams. 

• Interacts with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials, as well as ensure the clinical program is appropriately designed.

• Guides staff in 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.

• Identifies the need for new process improvement initiatives, and leads working groups to solve the process gaps.  Sets timelines and expectations for the deliverables.  Authors new/revised SOPs and contributes to cross-functional EPIC workstreams. 

• Identifies the need for new statistical methodology and leads research teams to establish required methodology. 

• Prepares presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies.  Co-presents findings to management. 

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

• PhD or equivalent degree in statistics/biostatistics with >8 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >13 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

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