Le contenu de ce poste est libellé en anglais car il nécessite de nombreuses interactions à l'international, l'anglais étant la langue de travail.

CONTEXT

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

As a Project Statistical Programmer, you will play a key role in supporting a growing pipeline focused on oncology, immunology & inflammation, rare disease and rare blood disease, with emphasis on trial conduct, innovative-driven solutions, and regulatory submissions.

You will provide leadership and guidance at the project/indication level, accountable for all the plan and execution of statistical programming activities, including support of fast ongoing decision making (early phase) or the submission of the data to Health Authorities (late phase).

You do not feel comfortable yet with all these expectations and really want to grow to embrace these responsibilities? Let’s get in touch, 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.

KEY ACCOUNTABILITIES

Major Duties and Responsibilities

• Lead, guide and support statistical programming deliverables within a project to ensure high quality and timely, technical validity, compliance to internal standards, quality documents and regulatory requirements
• Plan and execute statistical 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
• Collaborate effectively with project statistician and with other functions in the aligned project team to achieve project goals; participate in clinical project meetings and provide inputs, whenever relevant
• Support multiple intermediate study milestones and exploratory statistical analyses; drive and support fast ongoing decision making (early phase)
• Lead regulatory submission activities, including electronic submission packages (late phase)
• Promote teamwork, quality, operational efficiency, and innovation
• Identifying areas and processes that can be improved and finding new and innovative ways of increasing speed and efficiency 

Or at least

Programming study lead of a study: plan and execute statistical programming activities for the accountable study.

• Perform programming activities, including ADaMs, Tables/Listings/Figures (TLFs) and support documentation for all statistical deliverables (e.g. data monitoring committee reports, period safety reports, interim analyses, clinical study report, publications, exploratory analyses) within a study/project
• Perform quality control for statistical programming deliverables
• Review and provide feedbacks on study documents, such as protocol (statistical section), Case Report Form (CRF), Statistical Analysis Plan (SAP) and Table Listing and Figures (TLF) templates
• Write and provide the programming specifications for the Study Data Tabulation Model (SDTM) and Analysis Datasets Model (ADaM) for a study 

PROFILE

Required Education/Experience

• Post-graduate with at least 3+ (study lead)/5+ years (project/indication lead) of programming experience in processing clinical trial data in the pharmaceutical industry
• Technical skills in statistical programming (e.g. SAS, R)
• Knowledge on regulatory requirements understanding of pharmaceutical clinical development and ability to lead regulatory submissions
• Good communications and negotiation skills
• Ability to have efficient exchanges with partners, service providers, and colleagues across geographical locations
• Represent Sanofi in external communication: congresses, international working groups
• Strong skills that demonstrate initiative, motivation, and teamwork in global interdisciplinary teams
• Ability and mindset to embrace change, innovate and continuously improve programming practice

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

This is our Sanofi, Discover yours!

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.