The Programming Project Leader directs statistical programming activities for clinical development projects, primarily in Oncology and Neurology, ensuring high-quality, compliant deliverables. They manage resources, lead regulatory submission efforts, provide technical guidance, and collaborate with cross-functional teams globally. This role also involves overseeing outsourcing engagements and contributing to departmental initiatives for process optimization and standardization.
Job Title: Programming Project Leader
Location: Morristown, NJ
About the Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
Lead one or more statistical programming project team(s). Responsible for all programming activities at the project/indication level. Contribute to department initiatives and task forces.
Programming Project Lead (PPL) of a moderate size project / one or several indications of a project in late phase clinical development. With limited direction from group manager, plan and execute statistical programming activities for responsible project(s) in Oncology and/or Neurology.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
Provide leadership, guidance and hands-on support to ensure high quality and timely statistical programming deliverables within a project, ensure technical validity, compliance to internal standards and SOPs, regulatory requirements
Plan and track programming project activities, timelines, and resource use in cross-site global setting; provide justification for planned resource needs, seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas
Ensure standardization and consistency in specifications and programming deliverables across individual studies and for integrated analyses
Provide technical guidance and leadership to metadata specifications and project/study specific data requirements
Lead regulatory submission activities, including electronic submission packages
Supervise the quality controls (QC) methods and processes for programming deliverables in both study and submission level activities
Provide guidance to junior staff on programming techniques, project management and implementation of standards
Collaborate effectively with project statistician and with other functions in the aligned project team; participate in clinical project meetings and provide inputs, whenever relevant
Lead oversight activities for outsourcing engagements; guide team members to effectively interact with external resources
Participate in departmental initiatives; provide inputs to programming standardization and process optimization
About You
Required Education/Experience:
Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field
US: MS / BS with at least 5+ / 7+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry
Excellent technical skills in statistical programming, with advanced knowledge in SAS, R and other statistical computing software
Ability to perform, coordinate and oversee the preparation, execution, reporting and documentation of all programming deliverables of a project, with minimal supervision
Knowledge on regulatory requirement evolution (SDTM, SDRG, ADRG, ADAM, XML format, etc.); thorough understanding of pharmaceutical clinical development (i.e. statistical concepts, techniques and clinical trial principles) and ability to lead regulatory submissions
Ability to collaborate with external partners (CROs, Partners, etc.) and manage outsourced activities
Excellent verbal and written communication skills in an English global environment; ability to have efficient exchanges with partners, service providers, and colleagues across geographical locations
Strong skills that demonstrate initiative, motivation and teamwork in global interdisciplinary teams
Ability and mindset to embrace change, innovate and continuously improve programming practice
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information canbe found here.
statistical programming, clinical trials, project management, regulatory submissions, Oncology, Neurology, SAS programming, R software, data standardization, resource allocation
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