Senior Biometrics Transformation Lead
Il y a 3 jours
Ile-de-France
Institut De Recherche Pierre Fabre
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Qui sommes-nous ? Nous sommes les Laboratoires Pierre Fabre, leader mondial qui allie expertise pharmaceutique et dermo-cosmétique pour accompagner les consommateurs et les patients à chaque étape de leur parcours de soins. Notre portefeuille compte plusieurs franchises médicales et marques internationales dont Eau thermale Avène, Ducray, A-Derma, Klorane, René Furterer et Pierre Fabre Oral Care. En nous rejoignant, vous intégrez une entreprise riche de sens, où la dimension humaine est essentielle. Vous devenez acteur du "We Care Movement", un mouvement qui valorise l'excellence et l'innovation au sein d'équipes passionnées. Ensemble, nous repoussons les limites de la science pour unir santé et beauté au bénéfice de tous, car à chaque fois que nous prenons soin d’une seule personne, nous rendons le monde meilleur. Présents dans 120 pays et une équipe de plus de 10 000 collaborateurs, nous sommes fiers de créer un impact scientifique et humain, aujourd'hui et demain Si prendre soin est au cœur de vos valeurs, rejoignez les Laboratoires Pierre Fabre et devenez un acteur clé du "We Care Movement". Votre mission We are seeking a senior and highly experienced Transformation lead to join our Data Science and Biometrics (DS&B) group and lead the transformation of our biometrics operating model. At Pierre Fabre Group, we are committed to advancing Pharma R&D to deliver innovative treatments for patients. Our strategic focus areas include Oncology, Dermatology, and Rare Diseases. Our internal R&D pipeline, complemented by selected external opportunities, will shape the future of Pierre Fabre Pharma. The position is a strategic role for an expert statistician and/or statistical programmer with strong clinical development experience and leading projects, programs, teams, or matrix organizations. The successful candidate will combine deep technical credibility in biometrics with proven ability to drive cross-functional transformation, improve ways of working, strengthen internal ownership, and increase control over critical study and submission deliverables. You will work closely with Data Science & Biometrics, Clinical Development, Medical Writing, Clinical Operations, Regulatory Affairs, Quality Assurance, R&D IT, and external partners to implement a scalable and inspection-ready operating model across clinical data management, statistics, statistical programming, vendor oversight, and regulatory submission activities. The role will also contribute to our ambition to modernize biometrics through stronger adoption of clinical data standards, including CDISC SDTM/ADaM and USDM, modern statistical computing environments such as SAS and R/Posit, and fit-for-purpose use of automation and GenAI in a GxP-compliant environment. Your role within a pioneering company in full expansion:
Key Responsibilities
* Lead the execution of the Biometrics transformation roadmap, translating strategic priorities into concrete operating model changes, governance, processes, and measurable outcomes.
* Strengthen internal ownership and oversight of critical biometrics activities, including statistical strategy, statistical programming, TFL delivery, data management, quality control, and submission-related outputs.
* Prioritize and sequence competing initiatives across the biometrics transformation portfolio, helping teams arbitrate trade-offs transparently and align on what comes first.
* Define and implement pragmatic governance mechanisms to improve transparency, accountability, and predictability of study delivery, from FIH through registrational studies and regulatory submissions.
* Support the gradual internalization or reinforced oversight of selected high-value activities, in particular statistical programming, TFL delivery, data flow, and critical submission-related deliverables.
* Champion adoption of clinical data standards (CDISC SDTM/ADaM, USDM), modern statistical computing environments, and automation/GenAI opportunities across the biometrics data flow, in a GxP-compliant manner and pragmatic way.
* Establish robust RACI models and ways of working between internal teams, CROs, Clinical Development, Medical Writing, Clinical Operations, Regulatory Affairs, Quality Assurance, and R&D IT.
* Partner with Quality Assurance to ensure that transformed processes are compliant, documented, audit-ready, and aligned with GxP expectations.
* Facilitate senior-level workshops, governance meetings, and decision forums to align stakeholders, resolve bottlenecks, and accelerate adoption of new ways of working.
* Define and monitor transformation KPIs, including delivery predictability, quality indicators, vendor performance, internal oversight levels, process cycle times, and adoption of new governance models.
* Provide concise, executive-ready updates, recommendations, risk assessments, and decision support to DS&B
Key Responsibilities
* Lead the execution of the Biometrics transformation roadmap, translating strategic priorities into concrete operating model changes, governance, processes, and measurable outcomes.
* Strengthen internal ownership and oversight of critical biometrics activities, including statistical strategy, statistical programming, TFL delivery, data management, quality control, and submission-related outputs.
* Prioritize and sequence competing initiatives across the biometrics transformation portfolio, helping teams arbitrate trade-offs transparently and align on what comes first.
* Define and implement pragmatic governance mechanisms to improve transparency, accountability, and predictability of study delivery, from FIH through registrational studies and regulatory submissions.
* Support the gradual internalization or reinforced oversight of selected high-value activities, in particular statistical programming, TFL delivery, data flow, and critical submission-related deliverables.
* Champion adoption of clinical data standards (CDISC SDTM/ADaM, USDM), modern statistical computing environments, and automation/GenAI opportunities across the biometrics data flow, in a GxP-compliant manner and pragmatic way.
* Establish robust RACI models and ways of working between internal teams, CROs, Clinical Development, Medical Writing, Clinical Operations, Regulatory Affairs, Quality Assurance, and R&D IT.
* Partner with Quality Assurance to ensure that transformed processes are compliant, documented, audit-ready, and aligned with GxP expectations.
* Facilitate senior-level workshops, governance meetings, and decision forums to align stakeholders, resolve bottlenecks, and accelerate adoption of new ways of working.
* Define and monitor transformation KPIs, including delivery predictability, quality indicators, vendor performance, internal oversight levels, process cycle times, and adoption of new governance models.
* Provide concise, executive-ready updates, recommendations, risk assessments, and decision support to DS&B