Senior Specialist Biostatistician

Proclinical are recruiting for a Senior Specialist Biostatistician to join a pharmaceutical organisation. This role is on a permanent basis with the ability to work remotely from anywhere in Europe.

Responsibilities:

• Responsible for study planning and designing, which involves the statistical aspect of the protocol and final project.
• Accountable for developing the statistical analysis plan.
• Manage the sample calculation using simulations.
• You will plan and/evaluate the analysis from SAP and any exploratory analysis.
• Monitor and handle statistical and data management actions allocated to CRO.
• Offer precise indications for the design of the eCRF, IRT, ePRO and evaluate the linked technical specifications.
• Cooperate with others in preparing documents for scientific advice to regulatory bodies.
• Other duties may be assigned.

Key Skills and Requirements:

• Past involvement in a biostatistician role within a CRO.
• Acquaintance with working on phase I-III registration studies within the oncology area.
• Fluency in the English language.
• Expertise on SAS programming.
• Know-how of CIDISC standards, such as SDTM, ADAM, etc.
• Know-how of the main regulations such as EMA, FDA, etc.

If you are having difficulty in applying or if you have any questions, please contact Tom Magenis at +44 203 8541050.

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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