Job title: Project Programming Lead
About the JobAs Project Programming Lead within our Vaccines Biostatistical Sciences team, you'll lead the scientific programming of a large or couple of small project(s) from our vaccines portfolio, bringing data to life along the development value chain.
Assume responsibility for all scientific programming activities related to a late phase clinical development project or multiple projects in early or post-marketing phase. The incumbent provides technical and operational leadership, accountable for all programming activities for the related project(s). In addition, assume transversal responsibility like outsourcing operation management.
About YouBasic Qualifications- Masters degree in Statistics, Mathematics, Computer Science or related health sciences field.
- 7+ years of hands-on experience in SAS and R programming, proficiency in CDISC standards (SDTM/ADaM), and regulatory submission requirements.
Preferred Qualifications- Proven success performing, coordinating and overseeing the preparation, execution, reporting and documentation of all study and project-level asset development programming deliverables in a global setting. Proven experience in dealing with third party vendors.
- Demonstrated leadership that includes interpersonal skills necessary for effective teamwork in multi-cultural setting, ability to embrace and lead change, being curious to innovate and to bring improvement in the team practices where it adds value.
- Demonstrated experience implementing automation and digital transformation initiatives.
- Fluent in English; additional languages a plus.
Main responsibilities- Lead scientific programming deliverables - Provide leadership, guidance and hands-on support to ensure high-quality, timely programming outputs while ensuring compliance with internal standards, SOPs and regulatory requirements. Manage project planning & resources - Plan and track programming activities, timelines, and resource utilization in a global setting.
- Ensure standardization & consistency - Maintain consistency in specifications and programming deliverables across individual studies and integrated analyses.
- Drive regulatory submissions - Lead regulatory submission activities, including electronic submission packages, ensuring CDISC data packages comply with Health Authority expectations (FDA, PMDA, CDE, KFDA, etc.).
- Oversight activities for outsourcing engagements and guide team interactions with external resources.
- Collaborate cross-functionally - Partner effectively with project statistician(s); participate in clinical project meetings and contribute relevant inputs.
- Act into transversal responsibility, contributing to process improvement or ensuring outsourcing operation management (coordinate the CRO partnership from a business perspective; Ensure the operational quality and timely delivery through the follow-up of Key Performance Indicators (KPIs) and the organization of lessons learned meetings; Contribute to the maintenance of partnership governance and process documentation and any shared IT environments, such as Teams or SharePoint sites).
- Mentor - Provide guidance to junior staff on programming techniques and standards implementation.
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.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
The salary range for this position is:
$122.250,00 - $176.583,33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
