Senior Statistician

Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. Job Description In this role, you will: Lead all biostatistics activities related to clinical trials as responsible project statistician Communicate with project teams, clients and vendors on statistical questions Develop and review statistical sections of protocols, including sample size calculations Develop statistical analysis plans Develop and document analysis database structures (i.e. SAS analysis data set structures) Develop SAS program requirements and specifications SAS programming and program validation Review and QC of statistical deliverables (tables, listings, figures, etc.) Perform statistical analysis and report results Consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products Liaise with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics Participate in bid defense meetings and kick-off meetings Train statisticians and SAS programmers Prepare and deliver presentations at investigators' meetings Address audits findings/recommendations, and follow-up on and resolution of audit findings Qualifications MSc in Statistics or equivalent Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research Ability to apply a range of advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies Expert knowledge and understanding of the SAS programming Expert knowledge and understanding of CDISC ADaM standard Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH) Ability to work in English Additional Information Our mission is to be the best CRO in the world as measured by our employees, clients, sites, and vendors. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way.

Lead all biostatistics activities for clinical trials, including protocol development, statistical analysis plans, and database structure documentation. Communicate with project teams and clients while ensuring the quality and regulatory compliance of all statistical deliverables.

Requires an MSc in Statistics or equivalent with expert knowledge of statistical principles and SAS programming in a clinical research environment. Candidates must possess strong experience with CDISC ADaM standards and relevant regulatory guidelines such as FDA and ICH.

• Gestion de projetSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Biostatistics
• Clinical trials
• SAS programming
• Statistical analysis
• Protocol development
• Sample size calculation
• CDISC ADaM
• Data management
• Experimental design
• Regulatory compliance
• FDA guidelines
• EMA guidelines
• ICH guidelines
• Statistical validation
• Project management
• Statistical Analysis
• Research
• Auditing
• Medical Science
• Clinical Research
• Clinical Trials
• Content Analysis
• Database Storage Structures
• English Language
• Presentations
• SAS (Software)
• Statistical Methods
• Statistics
• Coordinating

• Science & Research
• Healthcare
• Data & Analytics
• Statistician
• Mathematicians, Actuaries and Statisticians
• Statisticians

Formation minimale

Maîtrise

Expérience minimale

5+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine