Manager, Statistical Programming

Regeneron Pharmaceuticals; Basking Ridge (NJ); On-site; USD 126,000 - 207,000; Full time

Job summary

An established industry player is seeking a Manager Statistical Programmer to lead programming activities within therapeutic areas. This role involves overseeing programming projects from study initiation to regulatory approval, ensuring timely and high-quality results. You will coordinate documentation, act as a technical resource, and support global regulatory submissions. Ideal candidates will have extensive SAS programming experience and a strong background in clinical data environments. This position offers a unique opportunity to influence and mentor a talented team while contributing to impactful projects in the biotechnology and pharmaceutical sectors.

Qualifications

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

Responsibilities

• Lead programming support for multiple studies ensuring high-quality results.
• Mentor and coach junior programmers to achieve project goals.

Skills

SAS Programming

Analytical Skills

R

Python

Interpersonal Skills

Leadership Skills

Organizational 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:

• 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 documentations and specifications for multiple studies following programming standards and processes.
• Act as a technical resource for the programming group to provide advice on complex programming tasks, standards, and processes.
• Support global regulatory authority submissions including preparing programming results for submission and working closely with partnering functions to address health authority requests.
• Participate and contribute towards department goals and SME topics.
• Mentor and coach new hires and junior programmers.

This role may be for you if you have:

• 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.
• 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.
• 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.
• 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