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.

At Intego Group, we value all employees and job candidates as unique individuals, and we welcome the variety of experiences they bring to our company. As such, we have a strict non-discrimination policy. We believe everyone should be treated equally regardless of race, sex, gender identification, sexual orientation, national origin, native language, religion, age, disability, marital status, citizenship, pregnancy, or any other characteristic protected by law.