What are the responsibilities and job description for the Project Programming Lead position at BioSpace?
Job title: Project Programming Lead
Location: Morristown, NJ
About The Job
As 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.
Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.
About Sanofi
Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.
About You
Basic Qualifications
Bachelor's degree in Statistics, Mathematics, Computer Science or related health sciences field.
7 years of hands-on experience in SAS or 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 its 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.
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.
#GD-SP
#vhd
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Location: Morristown, NJ
About The Job
As 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.
Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.
About Sanofi
Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.
About You
Basic Qualifications
Bachelor's degree in Statistics, Mathematics, Computer Science or related health sciences field.
7 years of hands-on experience in SAS or 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 its 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.
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.
#GD-SP
#vhd
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.