Director Biostatistics - Global Pharma

Proclinical are partnering with a pharmaceutical organisation who are currently recruiting for an individual to join their team. This role is on a permanent basis and is located in Paris as well the ability to work remotely. The opening position is for a Director Biostatistics - Global Pharma.

Responsibilities:

• The ideal candidate will serve as a contributor to project planning.
• Work alongside internal and CRO team members to arrange the planning and implementation of biostatistics deliverables with quality in a timely manner.
• Offer oversight and leadership to guarantee CRO partner comprehends the nature of the clinical data being gathered and the approaches to summarising the information.
• You will validate and QC CRO's work to guarantee the quality and precision of the statistical deliverables.
• Operate at a project-level in a lead biostatistician role within cross-functional team(s).
• Assist with preparing and validating analysis for use in regulatory documents and scientific articles, as well as with internal ad-hoc and exploratory analysis.
• Other duties may be assigned.

Key Skills and Requirements:

• Prior involvement in common and enhanced statistical strategies adopted in adoptive design.
• Knowledge in implementing, analysing, reporting and the comprehension of descriptive and inferential statistics.
• Competent with 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.
• Educated to an advanced degree level in a statistics or biostatistics field with demonstrable experience in a pharmaceutical organisation.
• Know-how of broadly used clinical study designs and multifaceted study designs.
• Communication skills both verbally and in writing.
• Works well with others in a team.
• Project management capabilities with the capacity to manage own time efficiently.
• Acquaintance with rare disease drug development would be ideal.
• Regulatory proposal experience would be preferred such as US FDA, EMA, PDMA, etc.
• Fluency in the English language.

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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