Principal Biostatistician (FTE or Contract)

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. OVERVIEW The Principals Biostatisticians will work closely with clients and provide high level consulting services for statistical analysis, reporting, and statistical programming specific activities which may include development of statistics section of protocol, development of statistical analysis plan, randomization schedule, conducting statistical analyses, validating programming and reporting output, and developing statistical analysis report. Principal Biostatisticians will also work on statistical programming for development of analysis datasets, and clinical tables, listings, and graphs specific to trial reporting requirements. Principal Biostatisticians will work as needed assuring that all client work has met or exceeded client expectations. Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.  Your day to day: Provide consulting of statistics activities related to clinical trials. Fulfill the responsibilities of study statistician as required Provide mentoring and QC of statistical programmer’s outputs; define analysis data specifications. If required, validate the statistical models used for programming Act as study statistician - interact with client and with clinical team including programmers, clinical data managers, clinical protocol manager, and other relevant personnel. Ensure that programmers get correct specifications and data at appropriate time Develop, review, and finalize the statistical analysis plan Validate the programming deliverables and collaborate with applicable team members to rectify any issues related to statistical reporting and analysis Develop randomization schedule, specifications, and guidelines Wherever applicable, provide input in finalization of study specific data quality control plan and ensure appropriate data analysis and reporting Wherever applicable, develop, validate and finalize the study specific list of table and table shells for clinical study reports and for study specific deliverables Ensure that all comments from the clinical team with regards to statistical report delivered for study specific deliverables are being addressed appropriately Analyze the data and contribute to trial progression related decisions by providing necessary input during trial specific deliverables including but not limited to blinded data reviews, and interim analyses