Senior/Director of Biostatistics - REMOTE

Proclinical is seeking a Senior/Director of Biostatistics for a cutting-edge biotech company. This position has the opportunity to work remotely on the East Coast.

Must be eligible to work in the US.

Job Responsibilities:

• Represent statistics in cross-functional project and study teams in multiple projects
• Provide statistical input into Clinical Development Plans, Clinical Study Protocols, Clinical Study Reports, regulatory submission documents, and publications ensuring accurate deliverables
• Perform sample size calculations, develop statistical analysis plans and lead TLF development
• Perform statistical analyses and validate analysis results
• Oversee outsourced statistical CRO activities and deliverables ensuring highest quality
• Develop, implement and improve statistical processes and standards
• Support and participate in the development of departmental strategies
• Interact with global regulatory authorities.

Skills and Requirements:

• PhD or Masters in statistics or biostatistics
• Ten years (12 years for masters) in the pharmaceutical industry and/or CRO including submission experience
• Excellent knowledge of clinical study designs, statistical methods, adaptive designs, regulatory guidelines (ICH, FDA, EMA) and statistical software like SAS, EAST, and R
• Awareness of the bigger picture, strong orientation to quality, innovative and solution orientated thinking
• Preferred experience with clinical study designs in cell gene therapies (CAR-T, iNEST)

If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz at +(1) 323-306-2409 or m.hermiz@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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