Sanofi
Job Title: Programming Project Leader
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. 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. 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; provide inputs to programming standardization and process optimization
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
and manage outsourced activities
Excellent verbal and written communication skills in an English global environment; Ability and mindset to embrace change, innovate and continuously improve programming practice
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.
marital, domestic partnership or civil union status; disability; veteran or military status or liability for military status; domestic violence victim status;
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. 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. 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; provide inputs to programming standardization and process optimization
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
and manage outsourced activities
Excellent verbal and written communication skills in an English global environment; Ability and mindset to embrace change, innovate and continuously improve programming practice
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.
marital, domestic partnership or civil union status; disability; veteran or military status or liability for military status; domestic violence victim status;