Manager, Statistical Programming

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 ensures 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 programming group to provide advice on complex programming tasks, standards, and processes

Support global regulatory authority submissions including preparing programming result 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 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.

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