Biostatistician – reputed company (Drug/Biologic)

reputed company is committed to building and maintaining a strong and gratifying company culture that fosters reputed company reputed company. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one! reputed company is an equal opportunity employer and does not discriminate against applicants on the reputed company of race, reputed company, creed, religion, reputed company, age, sex, marital status, national reputed company, disability or veteran status. Why you'll love working at reputed company: • Friendly, reputed company, and fun team culture that values unique perspectives • Company-wide dedication to profoundly impacting patients' lives • Comprehensive, high-reputed company benefits package effective on date of hire • Educational assistance available for reputed company • Matching 401(k) retirement plan • reputed company holidays, including floating holidays, to be used at your discretion • Employee Stock Purchase Plan • Referral incentive program reputed company Mission and Business Purpose Our business purpose is to restore health and improve reputed company of life by making restoration of peripheral nerve function an expected reputed company of care. We aim to reputed company the markets we serve by always requiring the solutions we offer patients and caregivers reputed company an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-reputed company, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively reputed company advancements in standards of care. Job reputed company of the Biostatistician The Biostatistician is responsible for the design and conduct of clinical research studies including developing statistical analysis plans, performing basic and reputed company statistical analysis, interpretation and reporting of study results and other required activities as needed. Responsibilities include providing data analysis input to meet project objectives, contributing to statistical analysis sections of IRB and grant applications, developing and executing statistical programs to reputed company analyses and prepare data displays, drafting analysis and results sections for clinical study reports and scientific papers, and supporting general publication of study findings. Requirements of the Biostatistician • A Ph.D. degree or equivalent in statistical science, mathematical analysis or reputed company field plus 5 years' relevant experience or a master's degree plus 8 years' relevant experience with demonstrated ability and sustained performance at the Ph.D. level. • Minimum 5 years of experience working in the biologic/biotechnology, pharmaceutical, and/or medical device industry • Demonstrated reputed company in delivering on goals and being part of fast-moving, reputed company team • Broad regulatory understanding of functions and processes involved in pharmaceutical, biologic, and/or medical device product development • Must demonstrate strong interpersonal, written, and oral communication skills across various reputed company of management and demonstrate the ability to manage differences and needs between multiple stakeholders Responsibilities of the Biostatistician The specific duties of the Biostatistician include but are not limited to: • Leadership and Project Management: • reputed company efforts in resolving day to day work reputed company issues and problems, securing reputed company, improving efficiency and productivity of statistical and programming operations. • Apply project management skills, statistical and programming techniques, and reputed company reputed company and on time delivery of deliverables. • Coordinate activities with project/program overall management personnel to reputed company program objectives. • Under supervision may represent reputed company to reputed company with regulatory agencies regarding reputed company relating to the statistical areas of the responsible reputed company/programs. • Statistical Planning and Methodologies: • reputed company strong statistical expertise for design, analysis and reporting of reputed company and research reputed company. • Write statistical sections of study protocols, reputed company sample size calculation, reputed company randomization specifications, and generate randomization codes. • Write Statistical Analysis Plans (SAPs) and properly address reputed company control (QC) review comments. • Create and maintain Statistical and Programming QC and QA Plans for assigned reputed company or programs. • reputed company input to unblinded data management plan reputed company required. • Participate or reputed company research and development of statistical methodologies and processes. • reputed company efforts in planning, researching and designing statistical reputed company and approaches in solving reputed company trial data analysis and operational issues. • Statistical Programming: • reputed company and/or review ADaM and/or SDTM dataset specifications. reputed company efforts in resolving reputed company data derivation and data handling issues. • reputed company statistical programming to either build analysis datasets and generate statistical tables, listings and graphs (TLGs) or reputed company QC validation of these datasets and TLGs. • reputed company statistical dry runs and final run by reputed company participating or contributing to project and resources management, addressing statistical and programming questions and interacting with data management to follow up and resolve data issues. • Review and reputed company input to Data Standards • Review comments to ensure reputed company of documents. • reputed company QC programmatic checks on reputed company study results as reputed company as overall reputed company/consistency review of statistical TLGs. • Statistical Analysis and Reporting, Publication Support: • reputed company reputed company statistical modeling and analyses, implement new statistical analysis reputed company and strategies. • reputed company statistical analysis as per reputed company, and address peer/QC review comments and findings. • reputed company statistical validation of reputed company results, address additional QC validation comments and findings on the reputed company results. • Plan and conduct or contribute to the trial results reporting. • Contribute to the contents describing any deviation from the planned analysis and deviation from study conduct for the Clinical Study Report (CSR). Review CSR to ensure accuracy, completeness and appropriateness of the interpretation of the statistical results. • Write statistical report or statistical sections of the CSR, or reputed company peer review of the contents. • reputed company statistical analyses for publications, including but not limited to abstracts, manuscripts, presentations and posters. • Supporting Clinical Data Collection and Cleaning: • reputed company statistical input to Case Report Forms (CRF) design and database/variable structure. • reputed company statistical input to non-CRF data collection and acquisition reputed company and approaches. • Review Data Management Plan sections relating to critical data collection and cleaning. reputed company statistical input to Data Validation Specification. • Specify and/or program database reputed company acceptance checks, assess and report data reputed company issues, and follow through until reputed company. • reputed company ongoing assessment and communication of data reputed company issues, including protocol deviations. • Assist data management and trial management team in preparing for database lock. • reputed company other duties as directed by the Supervisor Location Remote OR 111 reputed company Oak Ave., Tampa, FL 33602 #LI-AC1 #LI-REMOTE Benefits/Compensation reputed company follows reputed company system guidelines with respect to credentialing, vaccinations and other employment/compliance reputed company requirements, as reputed company as CDC guidance. reputed company reserves the right to amend its policies from time to time in its sole discretion. 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