Qualifications

At least 10 years of experience as a biostatistician with a Master’s degree in statistics or biostatistics is required. Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures, and good programming practices. Demonstrates ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical trials. Displays excellent communication skills with demonstrated leadership ability.

Responsibilities

Providing statistical oversight across clinical trials in all phases and in a wide variety of therapeutic areas

Designing, planning, and executing Biostatistical components of clinical trials including study design, cross-functional risk assessment, writing Statistical Analysis Plans (SAP), inferential analysis programming, study reporting/submission

Functional lead responsibility for the statistics and programming portion of the study including accountability for timelines, budget, and resourcing of the study

Mentoring junior Biostatisticians through our structured graduate training program

Serves as the lead biostatistician on programs of studies or submissions, or on simple to complex individual studies

Serves as an independent reporting statistician on data monitoring committees

Develops statistical analysis plans and reporting specifications for simple to complex clinical studies

Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies

Performs senior review of TFLs and statistical analysis plans

Provides significant input in the development and review of CRFs, edit specifications, and critical variable lists

Performs lead review of TFLs and derived datasets for clinical studies

Contributes to clinical study protocols and clinical study reports

Reviews simple to complex randomization specifications and dummy randomization schemes

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