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Statistical Programming I&I and RD Team Lead - All Gender

Permanent contract
Chilly-Mazarin
Salary: Not specified
No remote work

Sanofi
Sanofi

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Job description

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail. 

I&I and RD Team Lead, Statistical Programming in Biostatistics & Programming Department

JOB SUMMARY

At Sanofi, we have a shared commitment to bring innovation and rigor to each clinical development program.

The statistical programming organization is built on the aspiration to be an expertise leader in value-driven data preparation, analysis, reporting and submission, and an impactful partner in E2E execution excellence.

We leverage modern technology and drive streamlined process to carry out statistical analysis deliverables with efficiency and quality, from clinical study setup to the preparation of electronic submission package, while addressing evolving industry standards and regulatory requirements. We cultivate a continuous learning environment and foster expertise and performance.

We emphasize quality, resource and process optimization, value added, and global collaboration.

Embracing these principles is key to succeed in the position.

We are looking for a Team Leader who will step in the operational set up of the French Immunology & Inflammation (I&I) and rare disease/rare blood disease (RD/RBD) statistical programming team (<5 collaborators). The Team Leader will closely collaborate with the French, I&I, RD/RBD management teams, will manage the French I&I and RD/RBD study/project statistical programmers, and will act as a project programming leader on 1 or more projects.

You will be supported by a Biostatistics and Programming Department that fosters people development, offering compelling career opportunities that value diversity of thought and abilities, to optimize overall success and have a meaningful impact on patients’ lives.

MAJOR RESPONSIBILITIES

Statistical programming manager for a team of statistical programmers and programming project leaders supporting multiple clinical programming projects. With minimal direction from the group head, manage day-to-day team activities, plan and execute statistical programming support for the responsible project(s) to ensure operational and technical excellence

  • Provide team and project leadership, management, and technical guidance to ensure high quality and timely statistical programming deliverables that meet technical validity, regulatory requirements, and industry standards, via effective collaboration with peers, stakeholders and partners across the organization and geographical locations
  • Lead one or more clinical programming project(s)
  • Lead programming strategy development, e.g., submission, compound/project level technical approach, utilization of systems/tools, development/implementation of specific macros
  • Plan and track programming project activities, assignments, timelines, and resource use in cross-site global setting; optimize resource utilization across projects and respond to unscheduled changes in project workload with solutions
  • Manage team members priorities, performance review and development areas; promote teamwork, quality, operational efficiency, and innovation
  • Contribute to the departmental programming recruitment activities, coach junior staff on programming techniques, project management and standards implementation
  • Manage oversight activities for outsourcing engagements, with contribution to vendor selection, contract specifications, operation manuals, and service quality evaluation; guide team members to effectively interact with external resources
  • Lead departmental working groups on processes, standards, and programming technical topics; represent programming in cross-functional initiatives

PROFILE

Required Education/Experience

  • Postgraduate degree of science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field
  • Bac + 4/5 and at least 5+ years (or Bac + 2/3 and at least 10+ years) of programming experience preferably in processing clinical trial data in the pharmaceutical industry
  • Excellent technical skills in statistical programming, with advanced knowledge in statistical computing software (such as SAS, R, RShiny), in a clinical data environment across multiple therapeutic areas, with experience in leading large projects
  • Thorough understanding of pharmaceutical clinical development and regulatory submission process
  • Proficient knowledge in CDISC submission data requirements. Proven success in leading regulatory submissions
  • Demonstrated project leadership, project management, interpersonal skills
  • Experience in the development, evaluation and support of junior staff and flexible resources
  • 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
  • Ability and mindset to embrace change, innovate and continuously improve programming practice

Please provide your resume in PDF format and a motivation letter.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.

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