Position: BiostatisticianReports To: Director of BioAnalyticsDefinition: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 auditsSkills 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 RecordsAbility 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 accountabilityExperience 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