Work Schedule Standard (Mon-Fri) Environmental Conditions Office 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. What will you do in this role? Join our Clinical Research team as a Principal Biostatistician where you'll contribute to advancing life-changing therapies through statistical excellence. As part of our Functional Service Provider (FSP) division, you'll work closely with clients while utilizing the benefits and resources of an established leader in clinical research. You'll be responsible for implementing diverse statistical tasks throughout the full clinical trial process, from study design and protocol writing to final analysis and reporting. This position offers the opportunity to impact health outcomes while working with advanced clinical development programs. Qualification requirements Education requirements PhD or MS Biostatistics Degree in Biostatistics, Statistics or Math is required. PhD is highly preferred. 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. Experience requirements Minimum of 10 years of experience in clinical trials as study lead is required. Experience working with Phases 2 & 3 is required. Pharmaceutical experience is required. Experience with study design is required. Experience with protocol and SAP development is required. Experience working with clinical leadership is required. Strong statistical modeling experience is required. Client/vendor management is required. Expert-level proficiency in SAS programming and statistical methodology is preferred. Experience working with regulatory authorities (FDA, NIH, EMA, etc.) is preferred. Knowledge, Skills and Abilities Excellent oral and written communication skills Strong organizational and time-management skills Solid organizational and time-management skills Expert-level proficiency in SAS programming and statistical methodology Strong knowledge of ICH-GCP guidelines and clinical trial regulations Demonstrated experience in statistical analysis plan development and review Ability to manage multiple clinical trials simultaneously Demonstrated ability to work collaboratively in teams Ability to meet deadlines and manage competing priorities Strong attention to detail and quality focus Location Fully remote on the East Coast in the United States. Relocation assistance is NOT provided. • Must be legally authorized to work in the United States without sponsorship. • Must be able to pass a comprehensive background check, which includes a drug screening. 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 at 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. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. 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. Compensation and Benefits The salary range estimated for this position based in North Carolina is $182,000.00–$230,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes • A choice of national medical and dental plans, and a national vision plan, including health incentive programs • Employee assistance and family support programs, including commuter benefits and tuition reimbursement • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit https//jobs.thermofisher.com/global/en/total-rewards Apply tot his job Apply To this Job Apply tot his job Apply To this Job Apply To This Job Apply To This Job