Sr Biostatistician II

Thermo Fisher ScientificRemote, North Carolina, USAremoteSalary not postedView the original posting at Thermo Fisher Scientific ↗

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. As part of our clinical research portfolio, our prospective real-world studies evidence-based solutions specialize in generating data intelligence and clinical insights needed to bring safe and effective treatments to market. Your objectivity and dedication to patient safety will improve health outcomes that people and communities depend on – now and in the future. What will you do in this role? Functions independently as a lead statistician with minimal oversight to deliver the project statistician tasks/responsibilities, including analysis database creation, statistical analyses, and creation of formatted statistical analysis tables and summaries. Provides mentorship to junior team members. Essential Functions: • Ensures compliance with the activities outlined in the department's SOPs and contribute changes as needed. Follows departmental procedures for statistical analyses and programming work. • Work independently as a project lead or as lead statistician to deliver on lead tasks/responsibilities across challenging projects; provides senior review on projects. Leads team members across multiple complex projects. Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed. • Reviews sample size calculations and protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Contributes to writing appropriate protocol sections. Reviews randomization related documentation. • Writes / reviews analysis plans and guide others on the team in its implementation. Defines appropriate methods and procedures for statistical analysis. Reviews statistical analysis for key efficacy endpoints. • Reviews specifications for analysis database, oversees its development, and assures completeness for use in all programming. Oversees collaboration with programmers and data management personnel as to database maintenance, updating, and documentation. Supervises creation of table and listing specifications. • Prepares reports, manuscripts, and other documents. Contributes statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents. • Monitors project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope. Communicates with sponsors concerning project work scope and budgetary changes after reviewing with management. • Mentors members of the department by providing project guidance and statistical advice and by promoting employee development, contributing to performance planning, and providing resource planning. • Provides input on hiring recommendations, department policies, and resourcing requirements. • Acts as representative of the department to other divisions. Assists in bidding and business development activities. Consults with business development with respect to bids and timelines Hiring Qualifications: Education requirements: Masters in Biostatistics, Statistics or Math at a minimum is required In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Experience requirements: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’). Project lead client facing experience is r

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