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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: Functions independently as a lead statistician with minimal oversight to deliver the project statistician tasks/responsibilities, including analysis database creation, statistical analyses, and creation of formatted statistical analysis tables and summaries. Provides mentorship to junior team members. A day in the Life: - Ensures compliance with the activities outlined in the department's SOPs. Follows departmental procedures for statistical analyses and programming work. - Leads a project team. Conducts team meetings, maintains project timelines, assesses resources needed, provides resources, and prepares the budget. Ensures thatSOPs are being followed and that appropriate project documentation is ongoing. - Interacts with the sponsor on all aspects of the project. - Coordinates with programmers and data management personnel as to database maintenance, updating and documentation. Provides guidance for database structures for analysis. - Provides sample size calculations and reviews protocols for completeness, appropriateness of clinical design, and sound statistical analysis. - Provides randomization schemes and appropriate documentation. - Develops statistical analysis plan, including analysis database and table and listing specifications, and guide others on the team in its implementation. - Programs/validates statistical tables with an emphasis on efficacy endpoints. Provides proper documentation and oversee the work of others who assist in programming/validating. - Reviews reports and other documents and manuscripts. Contributes to the statistical methods section and verify for completeness and consistency for report. - Monitors project budget as it relates to project work scope and communicates proactively with management concerning potential changes in work scope. - Provides general infrastructure support to the department. Examples could include presentation/ teaching at department, contributing to other general department documents or policies, assisting with newsletters, helping in department libraries, or training of new hires. Education - Master's degree in statistics, biostatistics, mathematics or related field. Experience - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’). - In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, Abilities - Solid SAS® programming skills (Proficient in BASE, STAT, MACRO and GRAPH) and understanding of database structures - Capable of providing mentorship and promoting teamwork in a multi-disciplinary team setting - Solid understanding of statistical principles and good statistical skills - Capable of creating study specifications and providing support in the review of data management documentation - Good project management skills as shown through management of multiple projects - Solid written and verbal communications skills - , including proficiency in the English language - Good organizational skills with the ability to adapt and adjust to changing priorities - Positive attitude and the ability to work well with others Work Environment Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: - Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. - Able to work upright and stationary for typical working hours. - Ability to use and learn standard office equipment and technology with proficiency. - Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. - May require travel. (Recruiter will provide more details.) Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. *This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
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