Manager, Statistical Programming, Pharmacometrics

Regeneron
Tarrytown, NY, United States
18 days ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Experience required
7 years minimum
Working hours
Regular working hours
Job source

Tech stack

Data Governance SAS (Software)

Job description

  • Lead programming and quality control activities for analysis datasets, tables, figures, and listings across multiple projects.
  • Coordinate pharmacometrics programming activities and deliverables with cross-functional teams and study stakeholders.
  • Create, maintain, and validate programming specifications that support standardized analyses and reporting.
  • Integrate data across studies to support exposure-response, population PK, and population PK/PD analyses.
  • Support regulatory requests, data-driven analyses, scientific publications, and conference presentations.
  • Lead creation and validation of electronic submission deliverables and supporting documentation.
  • Partner with multidisciplinary study teams to deliver high-quality clinical trial analyses and reports.
  • Drive process improvements, standards development, and departmental initiatives that enhance efficiency and compliance.

Requirements

  • Bachelor’s degree required; Master’s degree preferred
  • Must have 7-9+ years of progressive experience in statistical programming. Experience in pharma regulated environment preferred.
  • Advanced SAS programming experience within a clinical research or pharmaceutical environment.
  • Strong understanding of pharmacometrics analyses, including pharmacokinetics, immunogenicity, exposure-response, and population PK methodologies.
  • Experience supporting clinical study reporting, regulatory deliverables, and CDISC data standards.
  • Strong project management, communication, problem-solving, and cross-functional collaboration skills.
  • Ability to manage multiple priorities while delivering high-quality work in a regulated environment.

Benefits & conditions

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

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