Principal Biostatistician-- fully remote on the East Coast in the US!
myGwork - LGBTQ+ Business Community, Raleigh, NC, United States
Work Schedule
Standard (Mon-Fri)
Environmental Conditions Office
Job Summary 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.
Principal Biostatistician – Responsibilities 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
PhD or MS in Biostatistics, Statistics or Mathematics is required; PhD highly preferred.
In some cases, an equivalency (combination of appropriate education, training and/or directly related experience) will be considered sufficient.
Experience
Minimum of 10 years of experience in clinical trials as study lead.
Experience with Phases 2 & 3 trials is required.
Experience in study design: protocol and SAP development.
Experience working with clinical leadership.
Strong statistical modeling experience.
Client/vendor management experience.
Expert-level proficiency in SAS programming and statistical methodology preferred.
Experience with regulatory authorities (FDA, NIH, EMA, etc.) preferred.
Knowledge, Skills & Abilities
Excellent oral and written communication skills.
Strong 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 collaboration skills.
Ability to meet deadlines and manage competing priorities.
Strong attention to detail and quality focus.
Location & Eligibility 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, including drug screening.
Our Mission Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Apply Today Apply via our careers portal: http://jobs.thermofisher.com
Equal Employment Opportunity Statement 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
Telephone 1‑855‑471‑2255 for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process.
Compensation and Benefits Salary range (North Carolina): $182,000.00–$230,000.00.
Variable annual bonus may be awarded based on company, team, and/or individual performance results in accordance with company policy.
Comprehensive total rewards package includes:
Choice of national medical, dental, and vision plans, and health incentive programs.
Employee assistance and family support programs, commuter benefits, 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, short- and long-term disability in accordance with company policy.
Retirement and savings programs, e.g., competitive 401(k).
Employee Stock Purchase Plan (ESPP) for eligible colleagues to purchase company stock at a discount.
#J-18808-Ljbffr
Environmental Conditions Office
Job Summary 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.
Principal Biostatistician – Responsibilities 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
PhD or MS in Biostatistics, Statistics or Mathematics is required; PhD highly preferred.
In some cases, an equivalency (combination of appropriate education, training and/or directly related experience) will be considered sufficient.
Experience
Minimum of 10 years of experience in clinical trials as study lead.
Experience with Phases 2 & 3 trials is required.
Experience in study design: protocol and SAP development.
Experience working with clinical leadership.
Strong statistical modeling experience.
Client/vendor management experience.
Expert-level proficiency in SAS programming and statistical methodology preferred.
Experience with regulatory authorities (FDA, NIH, EMA, etc.) preferred.
Knowledge, Skills & Abilities
Excellent oral and written communication skills.
Strong 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 collaboration skills.
Ability to meet deadlines and manage competing priorities.
Strong attention to detail and quality focus.
Location & Eligibility 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, including drug screening.
Our Mission Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Apply Today Apply via our careers portal: http://jobs.thermofisher.com
Equal Employment Opportunity Statement 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
Telephone 1‑855‑471‑2255 for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process.
Compensation and Benefits Salary range (North Carolina): $182,000.00–$230,000.00.
Variable annual bonus may be awarded based on company, team, and/or individual performance results in accordance with company policy.
Comprehensive total rewards package includes:
Choice of national medical, dental, and vision plans, and health incentive programs.
Employee assistance and family support programs, commuter benefits, 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, short- and long-term disability in accordance with company policy.
Retirement and savings programs, e.g., competitive 401(k).
Employee Stock Purchase Plan (ESPP) for eligible colleagues to purchase company stock at a discount.
#J-18808-Ljbffr