Biostatistician Jobs

We are looking for Biostatisticians who will be members of cross-functional development teams and will contribute to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, they may have responsibilities for integrated summaries and/or supporting regulatory submissions. These individuals will develop collaborative relationships and work effectively with the Inference Sr. Director of Statistics, Medical Monitor, Projector Manager, Data Manager, PK Scientist, and other members of the study team. Biostatisticians will be individual contributors and will report to a Biostatistics Manager.

Primary Responsibilities :

• Ensures alignment with Project Manager and Heads of US and India Operations with regard to priorities and scope of work assignments. Proactively, informs Project Manager and Heads of US and India Operations of issues/risks to the project and potential remediations.
• Ensures programming team understands the nature of the clinical data being collected and the approaches to summarizing the information.
• Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access.
• Translates scientific questions into statistical terms and statistical concepts into layman terms.
• Communicates effectively with Inference project and functional leadership concerning project issues (e.g. data, technical, timelines).
• Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, clinical study reports, and other study level specification documents

Qualifications :

• Significant academic training in statistics, biostatistics or relevant areas of study. Master’s degree in statistics or biostatistics required. PhD degree in a field where significant statistical course-work has been a requirement will also be considered (e.g. genetics, economics, psychology).
• Ability to be flexible and adapt quickly to the changing needs of the organization
• Ability to organize multiple work assignments and establish priorities
• Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals
• Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements

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