Job Description
Manager Statistical Programming
The Manager Statistical Programmer will lead and support all programming activities per the project strategies within therapeutic area(s). The incumbent will work with management and study team, plan and manage 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. The incumbent will be responsible for leading the programming aspect of a project and working with internal partnering functions, stakeholders, and external functional service providers to ensure all the programming deliverables are delivered in timely manner with high quality. Oversees documentation to ensure consistent maintenance of code, logs, and output in a regulated environment. The incumbent will participate and contribute to process and methodology development for department goals and SME topics.
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 deliverables in assigned projects and areas. Coordinate programming documentations and specifications for multiple studies following programming standards and processes
Demonstrate company values and act as a role model by demonstrating excellence, competence, collaboration, innovation, respect, ownership, and accountability
Understand the scope of work, plan and complete the deliveries and timelines with the study team, programming lead and management
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 deliverable 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
Ensure adherence to standards, policies and processes surrounding statistical programming function and deliverables
This role may be for you if:
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 effectively manage multiple tasks and projects
Problem solving and innovative skills that demonstrate initiative and motivation
Ability to influence others, mentor, and coach junior programmers to achieve results.
Required Special Equipment and/ or programs
SAS, (Base, Stat, Macro, graph); SAS certificates a plus
To be considered for this opportunity you must have:
MS. (BS.) in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related discipline with 8+ (9+) years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry, including some project and people management experience.
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Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)