The Director of Statistical Programming Medical Affairs provides leadership to the statistical programming group in Medical Affairs, including Health Economics and Outcomes Research (HEOR). The incumbent oversees all activities related to statistical programming through multiple layers of management and senior-level staff. The incumbent supports the overall strategy for the programming group in alignment with the company and department's vision, mission, and values. The role will lead the effort across Medical Affairs projects to identify, initiate, develop, and implement programming standards, applications, processes, and training. The incumbent is accountable for addressing all administrative functions required for project and resource management to meet company and department goals. The incumbent will represent Medical Affairs Statistical Programming in coordination and collaboration with partnering functions and cross-departmental stakeholders on innovative solutions and quantitative decision-making.
In this role, a typical day might include the following:
We expect you would be responsible for all management functions, including internal team and external functional service providers, to ensure timely and high-quality results. Lead the development, dissemination, and implementation of programming standards, applications, processes, and training across multiple therapeutic areas.
Communicate and ensure dedication to the roles and responsibilities of the Medical Affairs statistical/system programming function
Prioritizes activities across projects and facilitates resolutions to project challenges between groups or individuals, crafting solutions to address business and operational challenges
We need you to regularly meet with the Statistical Programming management team for close collaboration with the clinical development statistical programming team to evaluate and develop solutions for project resourcing, quality, timelines, budget, standard processes, and training needs. Keeps senior leadership informed of decisions and issues which impact the department.
Works with the department leadership team to maintain metrics for key activities.
Provides statistical programming support and related training to teams, department, partnering functions, and collaborators.
Facilitates succession planning and maintains a leadership team with diverse skills, abilities, and competencies, meeting the business needs of Statistical Programming for excellent support during both clinical development and post-approval stages
This role may be for you if you have:
Expert SAS(required) and R (desired) programming skills in observational/real-world type of data environments and clinical data environments across multiple therapeutic areas. Experience in supporting post-approval studies/ clinical trials, including observational studies, PMR/PASS/PAES type of studies, disease/treatment registry type of studies, investigator-initiated studies/trials, and assessments of electronic health records like claims databases and preparation of health technology assessment (HTA) dossiers supporting health economics and outcomes research projects are strongly preferred
Extensive experience in medical affairs/post-approval area and execution of project user requirements, system design, validation plans, operational and performance protocols, research, and development of applications and toolkits for end-users.
Solid experience in managing the training material development and training implementation for the use of standardized systems in a global environment
Proven track record of working on global interdisciplinary teams. Strong interpersonal skills that demonstrate initiative, motivation, and respect for others.
To be considered for this opportunity, you must have the following:
MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field with 10+ (12+) years of programming experience, preferably in processing observational study data/real-world data/clinical trial data in the biotechnology, pharmaceutical, or health-related industry, including the history of successful project and people management, and expertise in multiple therapeutic areas.
SAS Certification is desirable, along with solid experience in R programming.
Deep understanding of the post-approval requirement and life cycle management in the pharmaceutical/biotechnology industry across multiple therapeutic areas (i.e., understanding of statistical concepts, techniques, uniqueness in post-approval statistical programming work and trial designs and principles)
Ability to manage and lead statistical programming efforts for post-approval regulatory requirements.
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)