Principal Biostatistician-- FSP-- East Coast US! in Raleigh

Principal Biostatistician

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.

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 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.

Compensation and Benefits The salary range estimated for this position based in North Carolina is $-$.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

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