The Manager of Biostatistics Medical Affairs will be responsible for product and indication within Medical Affairs.

In this role, a typical day might include:

As part of a collaborative Medical Affairs team, you will implement the overall strategy for the Medical Affairs (Biostatistics) group. You will be responsible for following departmental guidelines promoting teamwork, innovation, and motivation. They will provide feedback into, and promote the use of, Medical Affairs policies and process improvement work streams (scientific, systems and processes). Together with Medical Affairs and HEOR colleagues, they will provide strategic guidance for product(s) to LCM/HEOR/Publications strategy, define future research questions, plan and execute statistical analysis, provide input into Medical Affairs lifecycle management strategy and tactics, provide input into and align with the publication plan, and support HEOR studies intended for payer and reimbursement needs. Working in a dynamic team with a wide range of interfaces, the role requires both strategic and operational skills combining innovative statistical thinking with a strong sense of business acumen.

This role might be for you if can/have:

Worked with Medical Affairs leadership to implement and execute departmental strategy/goals/objectives.Serve as the statistical lead for product(s)/indication(s) within Medical Affairs with minimal guidance from senior Medical Affairs colleague(s).Statistical Expertise in Study Design and AnalysisProvides scientific/statistical input into research study design, formulates novel methods to problem solving, and independently develop the statistical analysis plan to implement those solutions.Author the Statistical Analysis Plan (SAP) to define the appropriate statistical analyses to address research questions, specifications for data derivation, specifications for the statistical analysis methodology, and the display shells for the outputs to be generated in collaboration with key stakeholders.Perform and/or oversee statistical analyses using SAS to generate tables, listings, and figures for use in publications/presentations and for internal purposes.Ensures quality of deliverables through appropriate testing and active review for completeness and accuracy including oversight of work packages outsourced to CROs (including developing and implementing an oversight plan).Maintain up-to-date with state-of-the-art statistical science by participating in scientific societies, constant review of the clinical and statistical literature, and translate and apply relevant innovative statistical methodology to everyday work.Strong communication skills to interpret, explain, and discuss results of complex statistical analyses to both technical and non-technical audiences.Provide substantial input into standards within Medical Affairs including statistical position papers, standard analysis/display catalogues, and SAS macro libraries.Further the technology, systems, and process infrastructure within Medical Affairs.Educate and disseminate knowledge throughout the organization for areas within the expertise of Medical Affairs.

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

PhD or equivalent degree in statistics/biostatistics with >2 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >7 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 designExpertise in statistical software such as R or SAS is required

#GDBDMJobs

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. 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.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$126,700.00 - $206,900.00