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Senior Biostatistician

at DOCS in Montpelier, Vermont, United States

Job Description

Senior Biostatistician

Ref #: 27681

Employment type: Freelancer – Full-Time

Location: United States

Posted: 15-Apr-2021

Description

DOCS is currently seeking an experienced Sr. Biostatistician for a home-based opportunity. This is a contract opportunity starting at and not limited to a 6 month duration.

Responsibilities:

• Perform all duties and responsibilities associated with the Senior Biostatistician role

• Provide statistical contributions including statistical review and quality control of Statistical Analysis Plans (SAPs), Table, Figure, and Listing (TFL) shells, Submission Data File (SDF) specifications (SDTM and ADaM), other key-study related documentation, protocol deviations, Data Quality Review (DQR), and other communications

• Assist in cross-functional study start-up activities, including but not limited to CRF review, database specifications review, Interactive Voice Response System (IVRS) specification review, data transfer plan (DTP)

• Complete statistical analysis of individual studies/projects

• Reviewing TLFs created by Statistical Programming for consistency and accuracy

• Collaborate with the statistical programming team for study deliverables

• Assist with study and systems audits

• Participate in regulatory submissions including CSR, IND safety update, Annual Report/PSUR, and integrated summaries of safety and efficacy in NDA and BLA Ensures the quality of data and accuracy of analyses in regulatory submissions (e.g., CSR) or publications.

• Collaborate with Medical Monitor, Clinical Research Associate (CRA), Medical Writer, Clinical Data Management (CDM), and Statistical Programmer in developing a clinical study protocol, case report forms (CRFs), and edit checks.

• Develop analysis specifications for Statistical Programmer and reviews/verifies analyses and programming codes for quality assurance

• Perform any additional tasks required

Qualifications

•Bachelor’s Degree in life science, statistics, mathematics, computer science, or related field is required (Master’s Degree is preferred)

• Minimum 5 years’ Pharma/CRO experience as a biostatistician supporting clinical trials for regulatory submissions

• Excellent oral and written communication skills

• Strong interpersonal skills which allow for cross-functional collaboration and clear communication

• Ability to collaborate and work well in a team environment

• Previous experience with Oncology studies

• Experience in the utilization of

Job Details

Company

DOCS

Location


Montpelier, Vermont 05633
United States

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Job Posting: JC181628356

Posted On: Apr 17, 2021

Updated On: May 27, 2021