DOCS Biostatistician - Remote in Topeka, Kansas
Biostatistician - Remote
Ref #: 17946
Employment type: Permanent - Full-Time
DOCS is currently seeking an experienced Senior Biostatistician for a home-based opportunity.
• 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 Bayesian statistics
• Strong knowledge of current CDISC standards for SDTMs and ADaM
• Experience with writing/reviewing statistical analysis plans, working on study protocol, study design, and ad hoc analysis
• Strong SAS programming skills applying statistical procedures appropriately based on SAP-defined analyses
• In-depth knowledge of clinical development including clinical operations, data management, and clinical study report preparation workflow
• North American or European regulatory experience and in-depth knowledge of FDA/EU regulations and guidelines
• Must be knowledgeable of statistical methods in clinical data analyses (from Phase I through Phase IV), including statistical procedures in analysis software (e.g., SAS), and regulatory regulations/guidelines.
DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.
DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.