Senior Manager Biostatistics - UK or France 100% WFH

Proclinical are recruiting for a Senior Manager Biostatistics - UK or France 100% WFH for a pharmaceutical organisation. This role is on a permanent basis with the ability to work remotely from either the UK or France.

Responsibilities:

• Offer oversight and direction to guarantee CRO partner comprehend the nature of the clinical data being gathered and the approaches to summarise the information.
• You will validate and WC CRO's work to guarantee the quality and precision of the statistical deliverables.
• Assist with preparing and validating analysis for use in regulatory documents and scientific articles.
• Cooperate with both internal and CRO team members to arrange the planning and implementation of biostatistics deliverables with quality and in timeline.
• The ideal candidate will both validate and QC CRO's work to guarantee the quality and precision of the statistical deliverables.
• Accountable for writing and evaluating key study documents, for example: study protocol, statistical analysis plan, dataset specifications, clinical study report, publications, and regulatory submission documents.
• You will serve as a key contributor in project planning.
• You will assist with preparing and validating analysis for use in regulatory documents and scientific articles.
• As the Senior Manager Biostatistics, you will work at a study-level biostatistician in cross-functional team(s).Offer oversight and direction to guarantee CRO partner comprehend the nature of the clinical data being gathered and the approaches to summarise the information.
• You will validate and WC CRO's work to guarantee the quality and precision of the statistical deliverables.
• Assist with preparing and validating analysis for use in regulatory documents and scientific articles.
• Other duties to be assigned.

Key Skills and Requirements:

• Acquaintance with common and advanced statistical strategy.
• Knowledge of implementing, analysing, reporting and the comprehension of both descriptive and inferential statistics.
• Educated to a PhD degree level in statistics or biostatistics with at least 4 years of experience working in a pharmaceutical organisation or educated to a MS degree level with at least 7 years of experience working in a pharmaceutical organisation.
• Expertise on broadly used clinical study design and multifaceted study designs.
• Competent in using statistical software tools. For example: SAS, R, EAST, nQuery, JMP, etc.
• Familiarity working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets.
• Communication skills both verbally and in writing.
• Works well in a team.
• Project management with the ability to manage own time efficiently.
• Prior involvement working with rare disease studies within a pharmaceutical environment would be ideal.
• Familiarity with regulatory submission, both US FDA and EMA would be preferable.

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan on h.hennigan@proclinical.com

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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