Senior Manager, Statistical Programming
Remote - United States
The Senior Manger Statistical Programming provides technical leadership and support to the project teams on all statistical programming matters according to the project strategies within therapeutic area(s). The incumbent manages the programming aspect of a project in collaboration with partnering functions, stakeholders, and external functional service providers for all programming deliverables from the single study through to regulatory approval, product launch, data monitoring boards, regulatory safety reports, and other requests. Oversees documentation and ensures consistent maintenance of code, logs, and output within a regulated environment. The incumbent will lead or participate in process and methodology development for department goals and SME topics. Maybe responsible for goal setting and performance management.
In this role, a typical day might include the following:
Manage and lead programming support within multiple studies/projects in various study activities to ensures timely and high-quality programming deliverables in assigned projects and areas. Lead and coordinate programming documentation including specifications, as appropriate, 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
Ensure the commitment and reinforcement of the roles and responsibilities of the statistical programming function
Proactive communication with study and project teams to clarify requirements and specifications, guide direct reports or support programmers on assignment status
Lead and support global regulatory authority submissions including preparing programming deliverable for submission and working closely with partnering functions to address health authority requests.
Lead and manage department goals and SME topics
May oversee development of direct reports by setting goals, managing performance, evaluating, and monitoring training needs, supporting development plans, mentoring, and coaching
May participate in screening and interviewing candidates for contractor and permanent positions.
Ensure adherence to standards and procedures surrounding statistical programming function and deliverables
This role may be for you if you have:
Advanced SAS programming skills in a clinical data environment with expertise in at least one, preferably multiple, therapeutic areas. 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
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 10+ (12+) 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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Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$145,400.00 - $237,200.00 ApplyJob Profile
Annual bonuses Comprehensive benefits Diverse culture Equity awards Fitness centers Health and wellness programs Paid Time Off
Tasks- Lead process development
- Manage programming deliverables
- Mentor junior programmers
- Oversee documentation
- Provide technical leadership
- Support regulatory submissions
Biotechnology Clinical Data Clinical Data Management Clinical Development Coaching Collaboration Communication Engineering Interpersonal Leadership Mentoring Organizational People Management Performance Management Pharmaceutical Problem-solving Product Launch Project Management Python R Regulatory Submissions SAS Statistical Concepts Statistical Programming Statistics Training
Experience10 years
EducationB.S. Computer Science Engineering Life Science Mathematics MS Related discipline Statistics
Certifications TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9