This position is for a qualified statistician/biostatistician to support Early Clinical Development and Exploratory Sciences.
As the Associate Director, Biostatistics, a typical day might include the following:
You 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 supervising 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 for early phase projects.
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.
Provide people-management and oversight
Lead and contributes to process improvement and technical working groups and sets timelines and expectations for the results. Authors new/revised SOPs and chips in to cross-functional EPIC workstreams.
Evaluate appropriateness of available software for planned analyses and determines 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-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 >6 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >10 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
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 amazing benefits including health and wellness programs, fitness centers and stock 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.