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Sanofi Group Programming Project Leader in Bridgewater, New Jersey

Job Summary:

The incumbent is a programming project lead (PPL), responsible for all programming activities at the level of a project, i.e. all studies and submissions. The incumbent:

  • Provides and maintains project plan for all projects/studies including milestones, tasks, and coordination of programming activities

  • Provides leadership and guidance to ensure high quality and timely statistical programming deliverables within a project, ensure technical validity, compliance to internal standards and SOPs, regulatory requirements

  • Ensures standardization and consistency of documents and programming deliverables across studies (clinical study reports, CSR) and for integrated analyses (ISS/ISE)

  • Provides technical guidance and leadership to metadata specifications and project/study specific data requirements

  • Plans and leads regulatory submission activities

  • Supervises the quality controls (QC) methods and processes for programming deliverables in both study and submission level activities.

  • Participates in clinical project meetings and provide input, whenever relevant

  • Identifies areas for improvements within a project and make suggestions for changes and implementation, as appropriate

  • Acts as mentor to junior staff with regard to programming techniques, project management and implementation of standards

  • Assists in the development, evaluation and support of junior staff and contractors

  • Provides technical expertise and hands-on support to the programming team

In addition, at the department level, the incumbent:

  • Leads/participates in working groups either within-department or as a department representative cross-function

  • Supports department initiatives and task forces and contributes to department standards and processes

Knowledge and Skills:

  • Excellent technical skills in statistical programming, with advanced knowledge in SAS, 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. understanding of statistical concepts, techniques and clinical trial principles) and ability to manage and lead regulatory submissions.

  • Excellent understanding of internal SOPs and industry regulations.

  • Ability to act as the key contact for programming management, to anticipate activities, alert for potential issues and propose adequate solutions.

  • 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, problem-solve and teamwork in global interdisciplinary teams.

  • Ability and mindset to embrace change and continuously improve programming practice.

Formal Education and Experience:

  • A candidate with a Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field, preferred.

  • A candidate with a Master degree and 5+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry.

  • A candidate with Bachelor degree and 7+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry.

Knowledge And Skills Desirable But Not Essential:

  • Experience with other operating systems and packages such as UNIX, MS Office

  • Experience with other Statistical and Graphics software packages such as R, SPLUS, JMP

  • Experience with an Electronic Data Capture (EDC), such as RAVE, Oracle Clinical

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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