Senior Manager Biostatistics - Global Pharma

Proclinical are recruiting for a Senior Manager Biostatistics - Global Pharma to join a biotech organisation on a permanent basis located in Geneva.

Responsibilities:

• Guide or be accountable for the supervision of statistical analysis plans and any other statistical deliverables.
• Handle and troubleshoot operational difficulties, GCP compliance, and standardisation working alongside cross-functional associates rendering to the level of expertise.
• Participate in the development plans, idea sheets, protocols, clinical study reports, briefing books, ISS/ISE, proposal package, interacts with health authorities, etc.
• Work alongside cross-functional teams and external partners efficiently.
• Cooperate with biostatistics, programming and data management coworkers as well as pharmacometrician for contributions and information exchange to enable best practices across all studies/programs.
• Partake in CRO selection process and offer CRO oversight to accomplish high quality deliverables in agreed timelines and budget.
• Offer contributions to process improvement: examine new strategies or technologies when suitable; participate in the development, evaluation and update of BDM SOPs as company/situations advance.
• Other duties may be assigned.

Key Skills and Requirements:

• Educated to an advanced degree level in a statistics, biostatistics or similar field.
• Demonstrable experience within the relevant functional area.
• Knowledge of SAS.
• Capable of thinking outside the box, recognise connections between various areas of the business to see the wider perspective.
• Expertise on ICH and any other pertinent guidance documents such as from the FDA, EMA, etc.
• Presentation and communications both verbally and in writing.
• A motivate individual who is keen to work within a fast-paced setting.
• An organised individual with the ability to prioritise workload and work on various tasks simultaneously.
• A positive self-starter who is flexible and thrives while under pressure.

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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