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Key responsibilities and skills include, but are not limited to: RESPONSIBILITIES: Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for BA/BE, Dermatology and In-Vitro studies. Provide statistical oversight to studies and assure adequate quality and consistency with project requirements. Responsible for assuring that data for statistical analyses are complete, accurate and consistent. Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions. Responsible for validity of analysis and alternative analysis strategies when unforeseen circumstances arise. Effectively mentor peers with regard to statistical methodology and provide appropriate background, motivation, and training to less experienced statisticians. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES - Excellent written and oral communication skills - Excellent attention and accuracy with details - In-depth knowledge of applicable clinical research regulatory requirements (GCP, ICHE3, ICHE9) - Strong individual initiative / organizing skills / commitment to quality - Solid working knowledge of WinNonlin and SAS computing package - Ability to effectively manage multiple tasks and projects - Ability to provide and accept direction of lead team members - Ability to establish and maintain effective working relationships with coworkers, managers & clients - Working knowledge of relevant Data Standards (such as CDISC/ADaM) Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying. .