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Manager, Statistical Programming

Regeneron Pharmaceuticals

United States

Remote

USD 126,000 - 207,000

Full time

30+ days ago

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Job summary

An established industry player is seeking a Manager Statistical Programmer to lead programming activities across various therapeutic areas. This role involves collaborating with study teams and management to ensure high-quality programming results from study inception to regulatory approval. The ideal candidate will have extensive experience in SAS programming within a clinical data environment, along with excellent analytical and leadership skills. You'll be instrumental in mentoring junior programmers and influencing project outcomes while contributing to regulatory submissions. If you're looking for a dynamic and impactful role in a forward-thinking environment, this opportunity is perfect for you.

Qualifications

  • 8+ years of programming experience in clinical trial data processing.
  • Strong understanding of statistical concepts and regulatory submissions.

Responsibilities

  • Lead programming support in multiple studies to ensure high-quality results.
  • Mentor and coach junior programmers while coordinating documentation.

Skills

SAS Programming
Analytical Skills
R Programming
Python Programming
Interpersonal Skills
Leadership Skills

Education

MS in Statistics
BS in Statistics
Degree in Computer Science
Degree in Mathematics
Degree in Engineering
Degree in Life Science

Job description

The Manager Statistical Programmer will lead and support all programming activities per the project strategies within therapeutic area(s). They will work with management and study team, plan and own the implementation and execution of programming project standard to support from the single study through to regulatory approval, product launch, data monitoring boards, regulatory safety reports, and other requests. Be responsible for owning the programming aspect of a project and working with internal partnering functions, partners, and external functional service providers to ensure all the programming results are delivered in timely manner with high quality.

In this role, a typical day might include the following:

  1. Lead programming support within multiple studies/projects in various study activities to ensure timely and high-quality programming results in assigned projects and areas. Coordinate programming documentation and specifications for multiple studies following programming standards and processes.
  2. Act as a technical resource for programming group to provide advice on complex programming tasks, standards, and processes.
  3. Support global regulatory authority submissions including preparing programming results for submission and working closely with partnering functions to address health authority requests.
  4. Participate and contribute towards department goals and SME topics.
  5. Mentor and Coach new hires and junior programmers.

This role may be for you if you have:

  1. Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python, etc. is a plus.
  2. Understanding of pharmaceutical clinical development across multiple therapeutic areas (i.e. understanding of statistical concepts, techniques and clinical trial principles) and good knowledge of regulatory submissions and requirements.
  3. Ability to work on global interdisciplinary teams. Good organizational, interpersonal, communication, and leadership skills. Establish and maintain effective working relationships with coworkers, managers, and clients.
  4. Ability to influence others, mentor, and coach junior programmers to achieve results.

To be considered for this opportunity you must have:

MS. (BS.) in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field with 8+ (9+) years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health-related industry.

Salary Range (annually)

$126,700.00 - $206,900.00

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