Associate Biostatistics Director

il y a 4 jours

Paris, Île-de-France IQVIA Temps plein
  • Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
  • Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews. Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
  • Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
  • Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
  • Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA)
  • Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents.
  • Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge

Education

  • • PhD or MS in Biostatistics, Statistics or related field

Experience

  • Minimum of 8 years of experience in clinical trial statistics, preferably within a pharmaceutical or CRO setting.

  •   Technical Expertise:

  • Advanced proficiency in SAS / R for data analysis and statistical programming.
  • Experience with Bayesian methods, predictive modeling, and simulation techniques.
  • Proven track record in strategic study design, including adaptive designs, sample size calculations, and interim analysis planning.
  • Familiarity with regulatory guidance on statistical methodologies (e.g., FDA, EMA, PMDA).
  • Solid experience in applications of advanced statistical methodologies
  • Leading roles in regulatory submissions
  • Experience in interactions with major regulatory authorities preferred
  • Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy

  •   Study Design and Strategy:

  • Ability to lead statistical discussions during protocol development and study planning.
  • Skilled in defining statistical analysis plans (SAP) and developing strategic approaches for complex study designs.
  • Experience in strategy discussions involving adaptive design, go/no-go criteria, and futility analyses.

  •   Collaboration and Communication:

  • Strong communication skills to effectively present statistical concepts to cross-functional teams.
  • Proven experience in collaborating with clinical and regulatory teams to align statistical strategy with overall program objectives.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more

  • Freelance Associate Director, RWE

    il y a 4 jours

    Paris, Île-de-France Barrington James Temps plein

    Location:Remote / France-based (with occasional travel to Paris HQ)Project Duration:6–12 months (possible extension)Company:Leading Global Pharmaceutical CompanyProject OverviewWe are looking for a French-speaking freelance Associate Director with strong RWE and HEOR expertise to support evidence generation, value demonstration, and market access...

  • Associate Medical Director

    il y a 1 semaine

    Paris, Île-de-France Cytokinetics Temps plein

    Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of...

  • Associate Medical Director

    il y a 1 semaine

    Paris, Île-de-France Cytokinetics Temps plein

    Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of...

  • Associate Medical Director

    il y a 1 semaine

    Paris, Île-de-France CYTOKINETICS Temps plein

    Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of...

  • Associate Director HBCE

    il y a 3 jours

    Paris, Île-de-France HSBC Temps plein

    Associate Director HBCE (f/m/d) - Business Risk Regulatory Initiatives and CMA CIB – Poste réservé aux employés d'HBCE France Pour information, dans le cadre du projet de réorganisation des activités HBCE en France, les personnes actuellement éligibles à ce poste sont uniquement les collaborateurs d'HBCE en France, en CDI. Au regard des...

  • Associate Creative Director

    il y a 2 semaines

    Paris, Île-de-France SharkNinja Temps plein

    About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people's lives in homes around the world. , the company has a proven track record of bringing disruptive innovation to market, and developing one consumer product after another has allowed SharkNinja...

  • Pricing Associate Director

    il y a 2 semaines

    Paris, Île-de-France Wolters Kluwer Temps plein

    At Wolters Kluwer, our mission is to deliver deep impact when it matters most through protecting people's health and prosperity and contributing to a safe, sustainable, and just society. We are a portfolio of B2B software and information services companies serving professionals in the sustainability, health, legal, risk, tax and financial services spaces....

  • Senior Manager or Associate Director, Transaction Services

    il y a 5 jours

    Paris, Île-de-France Interpath Advisory Temps plein

    Interpath is an international and fast-growing advisory business with deep expertise in a broad range of specialisms spanning deals, advisory and restructuring capabilities. We deliver tangible results for global businesses, their investors, and stakeholders when complex problems arise, and critical decisions need to be made. Interpath is agile, independent,...

  • Associate Director or Senior Associate Director, Health Policy

    il y a 2 semaines

    Paris, Île-de-France APCO Worldwide Holdings Temps plein

    DescriptionWe are looking to hire a (Senior) Associate Director with health policy and communications experience to join our healthcare team in Paris. This role is a strategic account leader responsible for managing and growing client relationships within the healthcare and pharmaceutical sectors. This role focuses on leading integrated corporate...

  • Associate Director or Senior Associate Director, Health Policy

    il y a 2 semaines

    Paris, Île-de-France APCO Worldwide Temps plein

    We are looking to hire a (Senior) Associate Director with health policy and communications experience to join our healthcare team in Paris.This role is a strategic account leader responsible for managing and growing client relationships within the healthcare and pharmaceutical sectors. This role focuses on leading integrated corporate communications and...