Full-Time

Senior Manager

Statistical Programming

Posted on 6/12/2025

Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

10,001+ employees

Develops biopharmaceuticals for serious diseases

Compensation Overview

$148.3k - $241.9k/yr

Senior, Expert

Berkeley Heights, NJ, USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
SAS
Requirements
  • MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field with 9+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry.
  • Advanced SAS programming skills in a clinical data environment with expertise in at least one therapeutic area.
  • Extensive understanding of relational databases and experience working with complex data systems.
  • Experience in pharmaceutical clinical development and ability to provide programming support and leadership for BLA and other regulatory submissions.
  • Experience in working on a submission to regulatory authorities.
  • Knowledge of regulatory requirements concerning electronic submission standards.
  • Experience in creation of current CDISC data structures.
  • Leadership experience, especially in the hiring, development, evaluation and support of junior staff and contractors.
Responsibilities
  • Independently coordinate and oversee the preparation, execution, reporting and documentation of project analysis programming using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming deliverables.
  • Manage and coordinate programming and QC of analysis datasets and TFLs following Regeneron standard data models and/or integration of data across studies in support of CSS/CSE and esub deliverables.
  • Implement and mentor others on the use of department standardization tools or therapeutic area standard analysis when programming clinical data or system application deliverables.
  • Programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports.
  • Develop data models, programming standards and code, and training end users in project standards to support programming results that follow regulatory submission requirements.
Desired Qualifications
  • Experience in pharmaceutical clinical development and ability to provide programming support and leadership for BLA and other regulatory submissions.
  • Experience in working on a submission to regulatory authorities.
  • Knowledge of regulatory requirements concerning electronic submission standards.
  • Experience in creation of current CDISC data structures.
Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

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Regeneron Pharmaceuticals develops medicines aimed at treating serious diseases such as cancer, eye diseases, and allergic conditions. The company uses its own technologies and extensive research to create new therapies, often working with academic institutions and other pharmaceutical companies to enhance its efforts. Unlike many competitors, Regeneron focuses on both research and commercialization, generating revenue through the sale of its approved medicines and partnerships for co-development. The goal of Regeneron is to improve patient outcomes by providing effective treatments and ensuring they meet safety standards.

Company Size

10,001+

Company Stage

IPO

Headquarters

Town of Greenburgh, New York

Founded

1988

Simplify Jobs

Simplify's Take

What believers are saying

  • Regeneron's acquisition of 23andMe enhances its consumer genomics capabilities.
  • Dupixent's success in phase 4 trials strengthens Regeneron's position in respiratory biologics.
  • Investment in Alnylam Pharmaceuticals indicates strategic interest in RNA interference technology.

What critics are saying

  • Regeneron's acquisition of 23andMe may face regulatory and privacy challenges.
  • Failure of AERIFY-2 study could impact investor confidence in COPD treatments.
  • Intensifying competition in biologics market pressures Regeneron to innovate continuously.

What makes Regeneron Pharmaceuticals unique

  • Regeneron excels in developing life-transforming medicines for serious diseases.
  • The company leverages proprietary technologies for innovative drug discovery.
  • Regeneron's strategic partnerships enhance its research and development capabilities.

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Benefits

Health Insurance

Wellness Program

Paid Vacation

Equity Awards

Annual Bonuses

Flexible Work Hours

Company News

PharmiWeb
Jun 16th, 2025
Eaaci: Dupixent Demonstrated Superiority Over Xolair (Omalizumab) In Chronic Rhinosinusitis With Nasal Polyps In Patients With Coexisting Asthma In First-Ever Presented Phase 4 Head-To-Head Respiratory Study

EAACI: Dupixent demonstrated superiority over Xolair (omalizumab) in chronic rhinosinusitis with nasal polyps in patients with coexisting asthma in first-ever presented phase 4 head-to-head respiratory study New late-breaking data at EAACI showed Dupixent outperformed Xolair across all primary and secondary efficacy endpoints of CRSwNP and in all asthma-related endpointsDupixent also outperformed Xolair in improving such key signs and symptoms as nasal polyp size and sense of smell in CRSwNP, and lung function and disease control in asthma, with rapid improvements seen as early as 4 weeksResults reinforce the efficacy of Dupixent in treating both upper and lower respiratory diseases by targeting IL-4 and IL-13, two key drivers of type 2 inflammation Paris and Tarrytown, NY, June 15, 2025. Sanofi and Regeneron Pharmaceuticals, Inc. today presented positive results from the EVEREST phase 4 study of adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma. In the study, Dupixent (dupilumab) outperformed Xolair (omalizumab) on all primary and secondary efficacy endpoints of CRSwNP, and in all asthma-related endpoints. The data are from the first-ever presented head-to-head respiratory study with biologic medicines and were shared today in a late-breaking oral presentation at the 2025 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress, Glasgow, UK. Eugenio De Corso, MD, PhD ENT Specialist, Otolaryngology, Head and Neck Surgery, Rhinology, A

PharmiWeb
Jun 2nd, 2025
Itepekimab Met The Primary Endpoint In One Of Two Copd Phase 3 Studies

Itepekimab met the primary endpoint in one of two COPD phase 3 studies. AERIFY-1 study met its primary endpoint of a statistically significant reduction in moderate or severe exacerbations in former smokers regardless of eosinophilic phenotype and provided a clinically meaningful benefit. AERIFY-2 study, a second Phase 3 study, did not meet the primary endpoint despite a benefit seen earlier in the study

MarketBeat
Jun 1st, 2025
Summit Global Investments Invests $849,000 in Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY)

Regeneron Pharmaceuticals Inc. purchased a new stake in Alnylam Pharmaceuticals in the 4th quarter worth approximately $1,045,822,000.

CNBC
May 27th, 2025
23Andme To Delist From Nasdaq, Deregister With Sec

A sign is posted in front of the 23andMe headquarters in Sunnyvale, California, on Feb. 1, 2024.Justin Sullivan | Getty Images23andMe on Tuesday announced it will voluntarily delist from the Nasdaq and de-register with the U.S. Securities and Exchange Commission, according to a release. The move comes after Regeneron Pharmaceuticals said earlier this month that it will acquire "substantially all" of 23andMe's assets for $256 million. The drugmaker came out on top following a bankruptcy auction for 23andMe, a once high-flying genetic testing company that filed for for Chapter 11 bankruptcy protection in March.This is breaking news. Please refresh for updates

Pharmaceutical Technology
May 20th, 2025
ATS 2025: Sanofi and Regeneron to launch new AIM4 trial for personalised asthma care

At the American Thoracic Society (ATS) 2025 Congress on 19 May, Sanofi and Regeneron announced the launch of a new Phase IIIb/IV clinical trial, AIM4, during an evening industry symposium.