Biostatistician – Clinical Trials, Drug/Biologic

Job Description: • Lead efforts in resolving day to day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations. • Apply project management skills, statistical and programming techniques, and achieve quality and on time delivery of deliverables. • Coordinate activities with project/program overall management personnel to achieve program objectives. • Under supervision may represent the company to interact with regulatory agencies regarding matters relating to the statistical areas of the responsible projects/programs. • Provide strong statistical expertise for design, analysis and reporting of clinical trials and research projects. • Write statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization codes. • Write Statistical Analysis Plans (SAPs) and properly address quality control (QC) review comments. • Create and maintain Statistical and Programming QC and QA Plans for assigned projects or programs. • Provide input to unblinded data management plan when required. • Participate or lead research and development of statistical methodologies and processes. • Lead efforts in planning, researching and designing statistical methods and approaches in solving complex trial data analysis and operational issues. • Develop and/or review ADaM and/or SDTM dataset specifications. Lead efforts in resolving complex data derivation and data handling issues. • Perform statistical programming to either build analysis datasets and generate statistical tables, listings and graphs (TLGs) or perform QC validation of these datasets and TLGs. • Lead statistical dry runs and final run by actively 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. • Perform complex statistical modeling and analyses, implement new statistical analysis methods and strategies. • Perform statistical analysis as per SAP, 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 perform peer review of the contents. • Provide statistical input to Case Report Forms (CRF) design and database/variable structure. • Review and provide input to Data Standards. Requirements: • A Ph.D. degree or equivalent in statistical science, mathematical analysis or related 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 success in delivering on goals and being part of fast-moving, collaborative 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 levels of management and demonstrate the ability to manage differences and needs between multiple stakeholders Benefits: • Comprehensive, high-quality benefits package effective on date of hire • Educational assistance available for all employees • Matching 401(k) retirement plan • Paid holidays, including floating holidays, to be used at your discretion • Employee Stock Purchase Plan • Referral incentive program Apply tot his job