Senior Biostatistician

Ukraine/Poland/Romania

About the Position

Intego Clinical’s Biometric Department is expanding. We’re looking for bright individuals to join our growing team in Ukraine, Poland, and Romania offices.

As a Senior Biostatistician, you will be responsible for providing statistical oversight throughout the course of the study including: SAP/Shell creation, ADaM dataset specifications review, TLF validation, Statistical input to Study Protocol, Subject and Material Randomization, Sample-Size Estimation, identifying and collecting data issues and reporting them to DM.

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 the team to correct the mistakes.
• Interaction with the study team including data managers, programmers, etc. to coordinate actions and follow appropriate quality of deliveries.
• Represent the study team on the 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/Update/Maintain (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 be the 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 communication 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 the 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.

We Offer

• Competitive salary
• Opportunity to work in multiple countries
• Professional growth and development

About the Company

Join our team and contribute to the advancement of clinical research in Ukraine, Poland, and Romania.