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. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. In Biostatistics and Programming, we are passionate about data and technical agility to drive enhanced value for our customers and patients. Determined to improve patient health, we provide statistics, programming and clinical pharmacology expertise through global delivery, consistent quality adherence and scientific insight. Through a procedural framework based on robust planning and specifications, we deliver clinical trial planning and development programs, results of a study and lead the regulatory submissions. Discover Impactful Work: Performs advanced bioinformatics programming activities for the statistical and computational considerations of research projects. Works independently in a lead programmer role on select moderately complex studies, or may serve as a study team member under the direction of a lead programmer on more complex studies. Provides training and guidance to junior team members. A day in the Life: Serves as a lead programmer or project lead on studies or drug programs of all complexities and size scales. Works directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and ensure adherence to study budgets and any relevant contractual obligations or limits with clients. Suggests, plans and provides developments to tools and techniques for improving process efficiencies. Actively contributes to process or tool improvement efforts including leadership of solution teams. Represents the department to clients on study matters, bid defences or submission or review of clinical data to regulatory authorities, directly contributing to proposals and bids. May serve as company project manager on projects limited to only biometrics services. Provides general infrastructure support to the department, including representing the company at industry conferences, presenting/teaching at department meetings, assisting in establishing training materials, contributing to other general department documents or policies, and contributing to process improvement and department initiatives. Increases knowledge base and professional skills for self and junior team members if applicable, in areas including programming technology and techniques, clinical trials, and developments in the pharmaceutical industry. Provides feedback to managers on employee performance for employee development, performance reviews and training. Works to increase the visibility of the company by encouraging the publication of articles in industry journals and presentations at conferences. Contributes to the department recruitment/candidate interview process. Education and Experience: MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and at least 6 years of experience that provides the knowledge, skills, and abilities to perform the job requirements, or Bachelor\'s degree in computer science, statistics, biostatistics, mathematics or related field or equivalent and relevant formal academic / vocational qualification, and at least 8 years of experience that provides the knowledge, skills, and abilities to perform the job requirements. Knowledge, Skills and Abilities: Strong SAS programming skills, ADaM and TLF programming experiences are required. SDTM spec writing experience, programming and eCRT Define experiences are preferred. Great understanding of database structures and working with complex data structures Excellent verbal & nonverbal communication skills to facilitate communications with clients, project teams, departments and staff, including proficiency in the English language Capable of independently organizing, adapting, and adjusting to changing priorities across multiple assignments Good understanding clinical trials, ICH Statistical and reporting guidelines and GCP Excellent knowledge of statistical principles applied to the design and analysis of clinical trials Good understanding of the requirements involved in the submission of clinical data to regulatory authorities. Excellent project management skills, such as project budget creation, including modifying for project updates, and managing project budgets and risks

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