Senior Manager, Biostatistics Gene Therapy

The incumbent will work 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.

As the Senior Manager, Biostatistics, a typical day might include the following:

The incumbent will participate in regulatory agency meetings. The incumbent will co-author clinical study protocols, statistical analysis plans, and perform statistical analyses for interim and final reports. The incumbent will also develop and deliver training to non-statistical colleagues, lead the development of new infrastructure and processes, and influence the external pharmaceutical industry and regulatory environment through active participation in professional associations, conferences, and publications. As a Senior Manager, the incumbent will be responsible for mentoring and overseeing less experienced statisticians, with the potential to manage contract staff.

This role might be for you if you can:

• Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.

• Develops individual protocols and statistical analysis plans and determines appropriate statistical methodology for data analysis.

• Collaborates with Statistical Programming on the programming of tables, figures and listings to support decision making and for regulatory reporting.

• Evaluates appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools.

• Analyzes data and interprets results from clinical trials and of data from non-trial sources to facilitate program-level decision making.

• 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.

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

• PhD or equivalent degree in statistics/biostatistics with >4 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >8 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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