Senior Biostatistician

Proclinical are recruiting a Senior Biostatistician for a CRO. This role is on a permanent basis with the ability to work remotely from anywhere in France. The client is focused on distributing the customer's Phase II & III clinical trials on budget and in a timely manner.

Responsibilities:

• Guide all biostatistics actions linked to clinical trials as accountable project statistician.
• You will develop and evaluate statistical sections of protocols, which involves sample size calculations.
• Mediate with DM on statistical queries linked to data concerns, which involves arrangement of data transfers from DM to Statistics.
• Contribute to bid defense meetings and kick-off meetings.
• The ideal candidate will acknowledge audits discoveries/suggestions, and follow-up on and resolution of audit discoveries.
• Discuss experimental design, statistical processes and approaches for the purpose of evaluating safety and efficacy of drug products.
• Evaluate and QC of statistical deliverables, such as tables, listings, figures, etc.
• Other duties may be assigned to this role.

Key Skills and Requirements:

• Educated to a Master's degree level in a statistics or similar discipline.
• Expertise and comprehension of the statistical principles, ideas, strategies and standards used in clinical research.
• Know-how and comprehension of the SAS programming language, as well as advanced know-how of SAS software.
• Capable of implementing a variety of advanced statistical practices in assistance of clinical research studies as well as examine, comprehend, and draw conclusions from multifaceted statistical information.
• Able to consult with clinical investigators, comprehend research needs, and determine statistical analysis tactics.
• Expertise know-how of CDISC ADaM IG 1.0 or later, outline 2-0-0.xml specifications.
• Know-how of pertinent guidelines and regulations such as FDA, EMA, ICH.
• Presentation and communication skills both verbally and in writing.
• Fluency in the English language.

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at +44 203 854 1033.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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