Director of Statistical Programming Medical Affairs

3 days ago

Trenton, New Jersey, United States Regeneron Pharmaceuticals Full time
Job Title: Director, Statistical Programming Medical Affairs

Job Summary:

The Director of Statistical Programming Medical Affairs will provide leadership to the group in Medical Affairs, including Health Economics and Outcomes Research (HEOR). The incumbent will be 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.

Key Responsibilities:

  • Provide leadership to the statistical programming team in Medical Affairs, including HEOR.
  • Develop and implement programming standards, applications, processes, and training across Medical Affairs projects.
  • Collaborate with the clinical development statistical programming team to evaluate and develop solutions for project resourcing, quality, timelines, and budget.
  • 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.
  • Provide statistical programming support and related training to teams, department, partnering functions, and collaborators.

Requirements:

  • Expert SAS 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.
  • 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.

About Regeneron Pharmaceuticals:

Regeneron Pharmaceuticals 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.

Regeneron is committed to diversity and inclusion:

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.

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