Senior Manager, Biostatistics Job Summary
Summary of Job: Responsible for managing and overseeing all aspects of statistics and programming for COMPANY, including selecting vendors, tasks performed by vendors, interfacing with in-house staff and in establishing and maintaining global data standards and department procedures.
Essential skills needed for assignment:
Provides statistical expert support to regulatory submission and clinical studies in design, conduct, analysis, and interpretation of data analysis results.
Responsible for statistical sections of Protocols, Clinical Study Reports, and statistical analysis plans for all active development studies.
Participate in vendor selection process. Review or create Requests for Proposal, Work Order, Document specific requirements (e.g. systems, training records, SOPs), presentation/publication, and remain highly visible within the scientific community.
Supervises outside Statisticians at CROs in reviewing and approving statistical analysis plans and final analysis results for all development studies. In particular, ensures all statistical deliverables from CROs meet timelines, with quality. Oversee all aspects of statistics and programming tasks performed by vendor: Review CRF, database and dataset structure.
Interface with in-house staff: Participate on Project Teams; Review protocols, statistical analysis plans, and Clinical Study Reports; Work closely with Medical Monitor(s) to review SAP for logic, consistency and medical appropriateness.
Reviews protocols, case report forms, and specifications for study analysis data sets, clinical study reports, statistical analysis plans, and submission and publication analyses.
Assist Director, Biostatistics and/or VP, Head of Biometrics in identification, creation and maintenance of department procedures: Lead departmental initiatives related to process building/improvement and integration of new technology.
Assist in Regulatory Submissions
Coordinate and liaise global programming and database procedures, process and standards.
Ensures cross-study consistency in design and analysis for Clinical Development Plans.
Provides SAS programming and statistical analyses for publications and presentations of secondary study results of clinical trials.
Provides statistical input/guidance on project topics and issues in clinical and regulatory forums and meetings.
PhD in Statistics, Biostatistics, or related discipline with a minimum of 5 year experience or a Masters in Statistics with a minimum of 8 year experience.
5+ Years of working experience in clinical development.
3+ Years of experience in designing studies and analyzing data for clinical trials and/or early phase clinical pharmacology trials.
3+ Years vendor management experience in biostatistics in clinical trials.
Excellent statistical problem solving skills.
Excellent presentation skills
Excellent knowledge of CDISC standards
Very Good SAS programming skills
Very Good MS-Word/EXCEL/PowerPoint skills
Excellent Problem Solving Skills
Very Good Written and Oral Communication Skills
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