Statistician

POSITION SUMMARY The Biostatistician supports the Lead Biostatistician to provide a wide range of statistical expertise, guidance, and support, working with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. JOB FUNCTIONS/RESPONSIBILITIES Is involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians. Perform Lead Biostatistician role on simple studies, providing statistical oversight and attending relevant project meetings Maintain awareness of project tasks, and effectively communicate the status of such tasks to line management and the project manager, as appropriate Preparation of Statistical Analysis Plans (could include mock TFL shells) for simple and medium complexity studies under the supervision of senior statistical staff Perform statistical analysis for medium complexity studies Conduct overall statistical review of TFLs for medium complexity studies prior to client delivery Review CRF and other study specific specifications and plans Provide statistical input and review of the CSR for simple studies The Biostatistician II may also be included in, but not limited to, the activities and responsibilities listed below (responsibilities can be role and client specific): Sample Size Calculation Study Design Operating Characteristics / Simulation & Modelling Randomization Specification/Review eCRF/Edit Checks Review TLF Mocks ADaM Dataset Specification Input and Review ADaM Dataset Statistical Review TLF Statistical Review CSR Input and Review Publication Activities: Analysis planning and execution Publication input eSubmission/eCTD Review Public Disclosure Support (ex. Data Anonymization) DMC Participation/Support DMC (voting/non-voting) member Firewalled Blinded/Unblinded Statistician Planning and execution of any Ad Hoc/Exploratory Analysis Vendor Oversight and Quality Control Missing value imputation and sensitive analysis Adaptive design, sample size re-estimate and interim analysis Enrichment design and analysis Education/Requirement: MS (in Statistics or equivalent) or BS (in Statistics or equivalent) with 2+ years relevant work experience. Proficient knowledge of / experience with SAS/R/S plus or any other business or research analytic software. Proficient in up-to-date statistical knowledge/applications and proven experience in analytic aspects Experience in analytic support for multiple trials Proven knowledge in drug development Knowledge of data architecture Good interpersonal and communication skills