Director, Biostatistics - Early Clinical Development - Regeneron Pharmaceuticals, Inc.

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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Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)