Biostatistician – reputed company, Drug/Biologic

Job reputed company: • 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. • 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. • 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. • 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. • Plan and conduct or contribute to the trial results reporting. • Write statistical report or statistical sections of the CSR, or reputed company peer review of the contents. • reputed company statistical input to Case Report Forms (CRF) design and database/variable structure. • Review and reputed company input to Data Standards. Requirements: • 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 Benefits: • 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 Apply tot his job Apply To this Job