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Associate Director, Biostatistics FSP at Cytel

, , Spain -

Full Time

Start Date

Immediate

Expiry Date

16 Sep, 26

Salary

0.0

Posted On

18 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biostatistics, Clinical Study Design, SAS Programming, R Programming, CDISC Standards, Bayesian Design, Adaptive Design, Regulatory Filings, Oncology, Hematology, Statistical Analysis, Clinical Trial Documentation

Industry

Pharmaceutical Manufacturing

Description

Will be a lead statistician on individual studies, across related studies, and for integrated summaries and will design and report Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician. This role is responsible for all statistical aspects of study design, study analysis and validation, and study documentation. This person will provide timely and scientifically sound statistical expertise to clinical development projects and develop and execute statistical strategy, design, and analyses for clinical trials. This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.

Responsibilities

Lead statistician responsible for the design, analysis, and reporting of Phase I to IV clinical studies and regulatory filings. Collaborates across multiple clinical development functions to execute statistical strategies and ensure scientifically sound study documentation.