Biostatisticien Senior Adaptative Designs (ADs) études cliniques Cdi
Famille de fonction : Biométrie, Data managementgilleslaurent@ghlconsult.com
Description du poste et des missions
SOCIETE : GHLconsult est un cabinet de recrutement intervenant notamment dans les métiers de la santé. Notre Client est un laboratoire pharmaceutique conduisant un important programme de développements cliniques internationaux (1 phase I, 3 phases II & 8 phases III) pour lequel nous recherchons un(e) Biostatisticien(ne) senior pour renforcer ses équipes.
MISSIONS : Le poste couvre l'ensemble des tâches techniques généralement attribuées mais aussi la participation active aux rencontres avec le comité indépendant de contrôle des données, l'organisation des réunions de revue de données, la conduite des discussions statistiques ainsi que la collaboration avec les autres départements.
• Author the Statistical Sections of Protocol.
• Propose and Review the Study design.
• Calculate the sample size.
• Review the Case Report Form (CRF).
• Review the Edit Check Document (specifically for critical modules like RECIST 1.1 etc.).
• Write the randomization specifications and coordinate and finalize all the randomization activities with the IWRS vendor.
• Author Statistical Analysis Plan (interim and final as appropriate).
• Perform the Statistical Analysis (Efficacy and Safety (key safety like Adverse Events)) using SAS.
• Ensure quality of all the outputs developed.
• Perform the role of validator as appropriate.
• Provide Statistical Consultancy on an ongoing basis for projects.
• Perform Futility and Efficacy analysis as appropriate for interim analysis and interact with third party independent Statistician.
• Defend the Statistical Analysis at the IDMC meetings as appropriate.
• Write the specifications for the efficacy analysis. Review the Specifications for the Safety Analysis.
• Organize Data Review Meetings (equivalent to Blinded Data Review (BDR) or Dry Run) and lead all the statistical discussions.
• Work Collaboratively with the data management, Clinical Operations, Medical Writing and the Pharmacovigilance team as appropriate.
• Provide inputs to the regulatory affairs for all the discussions with the health authorities (e.g. ANSM, EMA, FDA).
• Review the Clinical Study Report and provide statistical inputs as appropriate.
• Perform exploratory analysis as appropriate.
MOTS CLES : STUDY DESIGN, RECIST, IDMC, BDR, ICH, DISC, CRF, AE, BAYESIAN, BOOTSTRAP
Profil souhaité
>Ph.D. in Statistics with minimum 3 years of relevant pharmaceutical (or CRO) industry work experience or Masters in Statistics or equivalent with minimum 5 relevant pharmaceutical (or CRO) industry work experience
>Good knowledge of core statistical methods such as MMRM, GEE, (missing data methods) Multiple imputation, JTR and Tipping analysis
>Experienced in advanced statistical approaches like Alpha control, estimand definition, and group sequential designs
>Good knowledge of SAS, preliminary working knowledge on R
>Good understanding of CDISC Concepts and of ICH guidelines
>Decent written and verbal English communications skills
>Good Team Player, Innovative mindset, Good interpersonal skills, good time management
Compétences requises
Au minimum 3-5 ans d'expérience en études cliniques phase 2 et 3 sur SAS
