Senior/Director of Biostatistics - REMOTE
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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.
- 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 email@example.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.