Associate Director, Biostatistics - Immunology

Overview

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.

• 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 plans and reviewing tables, figures, and listings 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 or revised SOPs and contributes to cross-functional work streams.
• 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.

• 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.

Salary range (annual): $ – $.

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, 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.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

Please note that certain background checks will form part of the recruitment process as required by law. Background checks will be conducted in accordance with the law of the country where the position is based.