at DOCS in Montpelier, Vermont, United States
Ref #: 27681
Employment type: Freelancer – Full-Time
Location: United States
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.
• 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
•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
Montpelier, Vermont 05633