Director Biostatistics - REMOTE job in Boston, USA

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Last Name*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

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Job type: Permanent

Discipline: Analysis, Statistics, Informatics

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a remote Director Biostatistics with a global biotech company.

In this position, you will be responsible for the implementation of mathematical concepts and statistical models in clinical research projects as well as participation in strategy and team development.

Job Responsibility:

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
Four years (6 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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