Senior Statistician

Visa Hunt; France; Sur place; EUR 70 000 - 120 000; Plein temps

Résumé du poste

Visa Hunt is seeking a senior biostatistician to lead all biostatistics activities in our clinical trials. You will write and review statistical sections of protocols, plan analyses, and validate SAS programs, while collaborating with project teams, clients, and vendors on statistical questions.

The role requires MSc in Statistics or equivalent, expert SAS knowledge, and experience with CDISC ADaM, FDA/EMA guidelines, and English communication.

Qualifications

• Expert knowledge of statistical principles and standards used in clinical research.
• Ability to apply advanced statistical techniques to analyze complex data.
• Ability to consult with clinical investigators and determine analysis strategies.

Responsabilités

• 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 SAS program requirements and specifications.
• SAS programming and program validation.
• Review and QC of statistical deliverables (tables, listings, figures).
• Perform statistical analysis and report results.
• Consult on experimental design and statistical methods for drug safety and efficacy.

Connaissances

Biostatistics

Clinical research

SAS programming

Statistical methods

English proficiency

Formation

MSc in Statistics

Outils

SAS

CDISC ADaM

Description du poste

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

• 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

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.

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.