Senior Biostatistician

Key responsibilities:      

• Development and review of statistical analysis plans.
• Review of the study protocols and other initial documents.
• Development and review of statistical programming notes as a part of SAP or as a separate guidance document.
• Create/Review ADaM specifications for adherence to CDISC standard as well as to protocol specified statistical considerations.
• Conduct third-line robust programming checks for efficacy outputs and/or outputs with advanced statistical calculations.
• Conduct overall statistical review of TFLs for medium complexity studies prior to client delivery.
• Provide statistical input and review of the CSR if requested.
• Review of outputs and further interaction with team to correct the mistakes.
• Interaction with study team including data managers, programmers, etc. to coordinate actions and follow appropriate quality of deliveries.
• Represent study team on project level. Deliver decisions made on the project level to study level team members.
• Prepare and review data transfer specifications and other study documents.
• Create/Updated/Maintaine (version control)  clinical trial documents and reports, protocols.
• Participate in study meetings (all departments). Lead departmental meetings as well as biometrics and meetings with sponsor, third-party vendors and other representatives.
• Develop study timelines. Keep the study in planned bounds.
• Provide guidance and being direct manager of less experienced biostatisticians.

Requirements:

• Minimum required Master’s Degree in Statistics, Biostatistics, or related field.
• 4-7 years of experience
• Pharmaceutical, CRO, or related industry experience with clinical trials.
• Strong oral and written communications skills, with the ability to effectively communicate internally and with clients.
• Demonstrated understanding and insight into statistics, drug development process, and relevant FDA regulations.
• Knowledge and understanding of the principles, concepts, methods, and standards of statistical research.
• Ability to apply a range of advanced statistical techniques in support of scientific research studies and/or experiments.
• Ability to process computer data and to format and generate reports.
• Ability to consult with scientific investigators, interpret research requirements, and determine statistical analysis strategies.
• Ability to plan, create, program and manage complex statistical analysis.
• Ability to analyze, interpret, and draw conclusions from complex statistical information.
• Knowledge of current and emerging trends in advanced statistical analysis for scientific application.
• Knowledge of SAS programming is a plus.
• Knowledge of scientific reporting and manuscript preparation requirements and standards.
• Ability to work in a team environment to design, analyze, and report on research projects.
• Strong analytical communication, critical thinking and problem-solving skills.
• Ability to provide technical guidance and leadership to professional personnel in area of expertise.
• Excellent time management skills and ability to prioritize projects.
• In-depth knowledge and understanding of probability and medical statistics theory.
• Knowledge of data management principles and regulatory requirements for clinical trials and medical research.
• Strong focus and quality and timely delivery of work.