Principal Biostatistician-- fully remote on the East Coast in the US!
About The Position
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.
Requirements
- PhD or MS Biostatistics Degree in Biostatistics, Statistics or Math is required. PhD is highly preferred.
- 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.
- Excellent oral and written communication skills
- Strong organizational and time-management skills
- Solid organizational and time-management skills
- 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
- 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.
Nice To Haves
- Expert-level proficiency in SAS programming and statistical methodology is preferred.
- Experience working with regulatory authorities (FDA, NIH, EMA, etc.) is preferred.
Responsibilities
- implementing diverse statistical tasks throughout the full clinical trial process, from study design and protocol writing to final analysis and reporting
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
