Senior/Director of Biostatistics - REMOTE job in Hoboken, USA

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First Name*

Last Name*

Email*

Phone Number*

Country*

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: Analysis, Statistics, Informatics

Location: United States

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

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.

#LI-MH2

Salary

Highly Competitive

Location:

Cambridge, USA

Proclinical is on the hunt for a bold, innovative thinker who is ready to help push the boundaries of science and make a tangible difference in the pharmaceutical world.