Regeneron
Biotechnology
SeniorManager,StatisticalProgramming
Neural analysis suggests this role is
optimal for Manager candidates.
“Senior Manager, Statistical Programming at Regeneron. Skills: Statistical programming, Clinical trials, SAS programming. Provide technical leadership. Manage programming aspect of a project”
Industry & Context.
Problem solving
What They're Looking For.
Must Have
MS (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline, 10+ years programming experience, 12+ years programming experience, Project management experience, People management experience, Advanced SAS programming skills, Expertise in at least one therapeutic area, Understanding of pharmaceutical clinical development, Good knowledge of regulatory submissions, Ability to work on global interdisciplinary teams, Ability to effectively manage multiple tasks and projects
Nice to Have
Programming experience in biotechnology, pharmaceutical or health related industry, Expertise in multiple therapeutic areas, Knowledge of R, Knowledge of Python
What You'll Do.
Provide technical leadership
Manage programming aspect of a project
Oversee documentation
Ensure consistent maintenance of code
Lead process development
Lead methodology development
Manage programming support within multiple studies
Ensure timely programming deliverables
Ensure high-quality programming deliverables
Lead programming documentation
Clarify requirements and specifications
Support programmers on assignment status
Lead global regulatory authority submissions
Prepare programming deliverable for submission
Address health authority requests
Lead department goals
Oversee development of direct reports
Set goals for direct reports
Manage performance of direct reports
Evaluate direct reports
Monitor training needs
Support development plans
Participate in screening candidates
Participate in interviewing candidates
How You'll Work.
Team & Collaboration
Project teams; Partnering functions; External functional service providers; Global interdisciplinary teams; Study teams; Project teams
Communication Scope
Communication
Process & Methodology
Project management
Full Job Description
_***Please note this role is an onsite opportunity and is NOT eligible remote._ The **Senior Manager 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:****** * 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 SM
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