Director, Statistical Programming Medical Affairs
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Tarrytown, New York
- Start date
- May 19, 2023
View more
- Discipline
- Clinical, Information Technology, Bioinformatics
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
The Director of Statistical Programming Medical Affairs provides leadership to the statistical programming group in Medical Affairs area. The incumbent oversees all activities related to statistical programming through multiple layers of management and senior-level staff. The incumbent supports the overall strategy for the programming group in alignment with the company and department's vision, mission, and values. The role will lead the effort across clinical projects in Medical Affairs area to identify, initiate, develop, and implement programming standards, applications, processes, and training. The incumbent is accountable for addressing all administrative functions required for project and resource management to meet company and department goals. The incumbent will represent Statistical Programming in coordination and collaboration with partnering functions and cross-departmental stakeholders on innovative solutions and quantitative decision-making.
In this role, a typical day might include the following:
We expect you would be responsible for all management functions, including internal team and external functional service providers to ensure timely and high-quality results. Lead the development, dissemination, and implementation of programming standards, applications, processes, and training across global therapeutic areas.
Communicate and ensure dedication to the roles and responsibilities of the statistical/system programming function
Prioritizes activities across projects and facilitates resolutions to project challenges between groups or individuals, crafting solutions to address business and operational challenges
We need you to meet with the Statistical Programming management team routinely to evaluate and develop solutions for project resourcing, quality, timelines, budget, standard processes, and training needs. Keeps senior leadership informed of decisions and issues which impact the department.
Works together with the department leadership team to maintain metrics for key activities within the assigned areas.
Provides support and training to team, department, partnering functions, and collaborators.
Facilitates succession planning and maintains a leadership team with diverse skills, abilities, and competencies, meeting the business needs of Statistical Programming
This role may be for you if:
Expert SAS programming skills in a clinical data environment across multiple therapeutic areas. Experience in supporting post-marketing clinical trials, registration studies, investigations, and assessments of claims databases, including health economics and outcomes research projects is a plus
Extensive experience in the global development and execution of project user requirements, system design, validation plans, operational and performance protocols, research, and development of applications and toolkits for end-users.
Extensive experience in managing the training material development and training implementation for use of standardized systems in a global environment
Proven track record to work on global interdisciplinary teams. Strong interpersonal skills that demonstrate initiative, motivation, and respect for others.
To be considered fir this opportunity you must have:
MS. in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field with 10+ years OR BS with 12+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical, or health-related industry, including the history of successful project and people management, and expertise in multiple therapeutic areas.
SAS Certification is desirable.
Strong understanding of pharmaceutical clinical development across multiple therapeutic areas (i.e., understanding of statistical concepts, techniques, and clinical trial principles) and ability to manage and lead regulatory submissions.
#GDBDMJobs
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)
$193,200.00 - $322,000.00Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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