Senior Statistician (CMC) job in Baltimore, USA

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Statistics, Data Management

Location: United States

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

Proclinical is seeking a Remote Senior Statistician for our client. The Senior CMC Biostatistician will be a statistical resource to support the development and commercialization of cell therapies in oncology. This will include direct support in the design and analysis of process and analytical CMC activities, as well as manufacturing and quality control.

Job Responsibility:

Provide statistical design and analysis supporting Process Development (including process development, process characterization, validation, and tech transfer/comparability)
Provide statistical design and analysis supporting Analytical Development (including analytical development, qualification, validation, and method transfer/reproducibility)
Perform analyses to support stability studies and shelf life/expiration dating
Provide statistical analysis support to MSAT and Manufacturing for continued process verification, optimization and comparability studies, and deviations and investigations
Provide statistical analysis support to ASAT and QC for reference and control qualification, method performance trending, and deviations and investigations
Engage cross functionally to promote collaboration and application of QbD principles

Skills and Requirements:

Master's or Ph.D. in Biostatistics/Statistics (or other related quantitative field)
5+ years of relevant industry experience as a statistician supporting CMC activities
Knowledge of theoretical and applied statistics, including statistical modeling, control charts, nonparametric methods, multivariate methods, and experimental design
Proficiency with statistical software tools (SAS, R, JMP, Minitab)
Strong verbal, written, and presentation skills
Experience with FDA regulations and other industry related guidance preferred

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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