Position: Biostatistician
Reports To: Director of BioAnalytics
Definition:
Works under the general supervision of the BioAnalytics Department hierarchy as
required, performing tasks related to the conduct of clinical trials. Under general direction
and guidance from the Senior Scientific Director, participates in the design of clinical trials
and research projects, the analysis and interpretation of data, and the dissemination of
results.
Essential Functions: The following duties represent the principle job duties; however,
they are not all inclusive:
❑ Participates in the investigational process from initiation to closing, as required
❑ Ensures adherence to Quality Assurance processes
❑ Participates in the development and review process of SOPs for the BioAnalytics
Department
❑ Develops statistical analysis plans, mock tables, programming and table
specifications
❑ Produces tables, Listings and Figures (TFL) and performs data review and statistical
analysis
❑ Assists in protocol development, sample size calculations, and case report form
(CRF) review
❑ Assists in writing statistical sections of integrated reports
❑ Advises data management staff on database design, validation checks and critical data
❑ Develops study specific randomization schedules
❑ Transfers study related data from client database and/or in-house developed database
into statistical analysis software
❑ Offers support on a variety of statistical issues
❑ Communicates with the sponsor and/or site representatives
❑ Reports, reviews and codes adverse events (including serious and non-serious)
❑ Organizes workflow in compliance with timelines
❑ Participates in department and project audits
Skills and Qualifications:Knowledge of:
❑ The CRO & Health Sciences industries
❑ MS Office
❑ Medical terminology and MedDra Software
❑ Experience with commercial statistical software (e.g. SAS, SPSS, etc...)
❑ Requirements of Good Clinical Practices
❑ Requirements of Good Documentation Practices
❑ Requirements of 21 CFR Part 11 for Handling of Electronic Records
Ability to:
❑ Comply with study timelines
❑ Assume multiple and concurrent tasks and responsibilities
❑ Perform independent research
❑ Work both independently and as an effective team member
❑ Provide attention to details
❑ Maintain and exhibit discretion at all times when handling confidential information
❑ Research and verify information
❑ Communicate effectively orally and in writing
❑ Establish and maintain cooperative and effective working relations with fellow
❑ employees
❑ Demonstrate behaviors that are shared at JSS Medical Research: integrity, respect,
❑ professionalism, commitment and accountability
Experience and Education:
❑ A minimum of a Bachelor’s degree or college diploma in Science or Life Sciences
❑ Relevant work experience with statistical analyses and/or clinical research