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Job Description
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Primary Role:
The Biostatistician works with the medical director, the regulatory lead and other clinical operations staff on the project team on clinical development plans; the design and conduct of clinical trials or registry studies; the evaluation, interpretation, and reporting of trial or registry results for publications; and regulatory submissions. The Biostatistician develops appropriate statistical methods for data analysis and ensures the accuracy and reproducibility of data sets and analyses of clinical trial or registry data by following relevant work practices and procedures. The Biostatistician may participate on project teams as the lead biostatistician on one or more multi-protocol projects within a therapeutic area. The biostatistician communicates with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results.
Responsibilities:
35%:
• Ensures all statistical work is processed on time to appropriate quality levels
• Reviews project protocols, authors protocol statistical analysis sections, including sample size calculations or simulations
• Generates and/or coordinates the creation of randomization schedules and ensures their accuracy
• Reviews case report forms to ensure that protocol objectives are met and project standards are maintained
• Develops statistical analysis plans for clinical trials or registry studies with fully documented table, listing, and
figure shells.
• Specifies statistical terms, equations for derived variables and algorithms for analysis
• Prepares documentation/specifications to support SAS code for analysis programs
• Understands and has the ability to use advanced statistical methods.
35%:
• Leads the analysis and reporting of results for clinical trials program or registry database, which may include
ISS and ISE, annual reports and/or other regulatory documents.
• Verifies statistical programs, data sets used and statistical results in regulatory documents and other
reports
• Develops SAS programs as necessary to perform planned or ad hoc analyses and prepare data displays
• Produces statistical reports as required
20%:
• Provides statistical interpretation of results and explains statistical methodology to team members
• Discusses statistical aspects of studies with medical director and regulatory authorities.
• Liaises with medical writers, interpreting statistical
results for input into clinical study reports or other documents
• Authors and/or reviews results sections of the clinical study report or other reports.
• Supplies statistical input for regulatory submissions and in response to health authority questions.
• Provides support for publication of clinical trial or registry database results.
10%:
• Assists in the Development of SOPs pertaining to Biostatistics and SAS programming, consistent with FDA and ICH regulations and guidelines.
• Participates in and/or leads process/quality improvement initiatives
• Provides leadership, quality review, and mentoring to less experienced biostatisticians which may include
coordinating the work of other biostatisticians and/or
programmers.
• Helps with the recruitment of biostatisticians
• Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature
review and attendance at workshops and professional meetings.
• Presents and discusses the statistical aspects of clinical trials to professional organizations, e.g. FDA reviewers,
or less technically oriented audiences.
Education & Experience Requirements:
• M.S. in Biostatistics or closely related field is required.
• Ph.D. in Biostatistics or closely related field is preferred.
• Generally 5+ years of relevant pharmaceutical experience.
Other Job Requirements:
Some domestic and international travel may be required
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