Principal Biostatistician Consultant, Oncology – Late Phase

Responsibilities

• Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned 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 explore alternative analysis strategies as needed.
• Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
• Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
• Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.
• Effectively mentor peers with regards to statistical methodology and provide appropriate training to less experienced statisticians.
• Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.

Requirements

• MS or PhD in Statistics, Biostatistics or related field. PhD with 2-4 years of experience or MS with 5-7 years of experience
• Strong SAS skills.
• Interpretation of data for internal team (clinical, stats..).
• Working on study readouts (AKA) analysis results from Tables listings and figures.
• Require Oncology TA experience.
• Strong oral and written communications skills, with ability to effectively communicate internally and with clients.
• Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations.
• Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.

Core Competencies

Demonstrates expertise in statistical analysis, protocol development, and oversight of clinical studies, with a strong focus on accuracy, consistency, and adherence to regulatory standards. Proficient in SAS and experienced in mentoring and managing statistical teams within the pharmaceutical or CRO industry.