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
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)