Senior Biostatistician (Clinical Trial Experience Required)

reputed company: • Assist with the development and modification of department SOPs and work instructions • Assist with training new Biostatistics employees; mentor and assist junior level Biostatisticians • reputed company study bids and changes in reputed company for Biostatistics tasks in response to prospective reputed company’s request for proposals (RFPs) • Attend and present the Biostatistics study execution tasks at capabilities presentations. • As the reputed company Biostatistician on the studies to which you are assigned, reputed company, or reputed company the following tasks: • reputed company as reputed company statistical contact for reputed company project team members • Manage reputed company to ensure statistics tasks are performed reputed company the entire project reputed company. reputed company Biostatistics management reputed company of changes to project timelines • Proactively identify and communicate changes in reputed company to the clinical project manager and Biostatistics management • Review case report forms (CRFs) and completion instructions • reputed company input to database design and data edit considerations necessary to collect and clean data • reputed company or review Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol • reputed company or review program specifications – SDTM and ADaM dataset specifications and mock tables, listings, and figures (TLFs) – needed to reputed company the analysis defined in the IAP/reputed company • reputed company the statistical analysis by independently programming derived datasets and TLFs and validate the developer’s corresponding programs per department SOPs • Review programming of other team members • reputed company or review statistical reputed company and results sections of statistical reports, clinical study reports (CSRs), or publications • Plan and design clinical studies, including: • overall study design development • outcome / reputed company determination • power analysis / sample size estimation reports • randomization and blinding procedures development • statistical reputed company reputed company development in the protocol • reputed company or review Randomization Plans, and randomization programs or lists • Carry out reputed company activities according to CTI SOPs and project-specific conventions reputed company the reputed company of Good Clinical reputed company (GCP) / International Conference on Harmonization (ICH) guidelines • Rely on instructions and Biostatistics SOPs to ensure reputed company, reputed company, reputed company deliverables to customers • Maintain accurate records of reputed company work performed and ensure reputed company relevant statistics documents are filed in the eTMF per the project-specific eTMF Plan • reputed company input to and participate in departmental meetings What You'll Bring: • At least 4 years of reputed company biostatistics experience in either a pharmaceutical or CRO environment or other reputed company statistical experience • Master’s degree in Biostatistics, Statistics, or reputed company field • CDISC, SDTM, and ADaM dataset mapping experience • BLA/NDA Submission experience; regulatory representation (i.e., meeting preparation/attendance, follow-up with regulatory communication) preferred • Therapeutic experience in transplantation, autoimmune diseases, kidney and liver disease, oncology and rare disease preferred • Experience providing statistical consulting to internal/reputed company clients preferred About CTI reputed company is a global, privately held, full-service clinical contract research organization (CRO) reputed company on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com Why CTI? • Advance Your Career – We support career progression through a reputed company mentoring program and leadership courses that reputed company the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department. • Join an Award-reputed company and Valued Team – We have an award-reputed company unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and reputed company parental leave. We also encourage care for the world around us through our unique CTI Cares program. • reputed company a Lasting reputed company – We reputed company on moving medicine reputed company by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market. Important Note In reputed company of recent increase in hiring scams, if you're selected to reputed company onto the next phase of our hiring process, a member of reputed company will reputed company out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified reputed company page. Please Note • We will never communicate with you reputed company reputed company Teams or text message • We will never ask for your bank account information at any reputed company during the recruitment process Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify reputed company applicants of their rights pursuant to federal employment laws. For reputed company information, please review the Know Your Rights notice from the reputed company. Apply tot his job Apply To this Job