The Director of Statistical Programming Medical Affairs provides leadership to the group in Medical Affairs, including Health Economics and Outcomes Research (HEOR). The incumbent is responsible for activities related to statistical programming through multiple layers of management and senior-level staff. The role will own the effort across Medical Affairs projects to identify, initiate, develop, and implement programming standards, applications, processes, and training.
In this role, a typical day might include the following:
- Responsible for all management functions, including internal team and external functional service providers, to ensure timely and high-quality results.
- Own the development, dissemination, and implementation of programming standards.
- Communicate and ensure dedication to the roles and responsibilities of the Medical Affairs statistical/system programming function.
- Prioritize activities across projects and facilitate resolutions to project challenges between groups or individuals, crafting solutions to address business and operational challenges.
- 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, and budget.
- Keep senior leadership advised of decisions and issues which impact the department.
- Provide statistical programming support and related training to teams, department, partnering functions, and collaborators.
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.
- 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.
To be considered for this opportunity, you must have the following:
Bachelor's in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field with 10+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry.
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) $198,000.00 - $330,000.00
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