Biostatistician II, Pharmacovigilance Focus- Fully remote!

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?

The Biostatistician II will work under the guidance of a Biostatistical Team Lead to implement statistical analysis plans involving complex longitudinal registry data available in several autoimmune disease areas. This individual will help to prepare appropriate analytic summaries and context for reports and publications.

CorEvitas Biostatistics team focus areas

• Query work: design, analyze, and report on research projects, i.e. queries, with clients to produce publications for the public domain (abstracts, posters, podium presentations, manuscripts, etc.)
• Pharmacovigilance work: design studies, analyze data, and develop reports to provide real‑world evidence regarding drug safety. Partner with pharma clients for long‑term post‑authorization safety studies to support FDA, EMA, or other regulatory commitments.
• Registry coordination: work cross‑functionally with Engineering, Clinical Data Management, and Project Management teams on all registry data, while incorporating client requests from the query and PV work.

A day in the Life of a Biostatistician II within this team:

• Compile, analyze, and report statistical data for various projects
• Conduct complex statistical analyses with supervision in accordance with statistical analysis plans
• Support the Biostatistical Team Lead in developing new statistical methodologies for data analysis
• Apply advanced statistical methods, which may include simulation models and other statistical programming, as needed
• Review relevant literature and existing data, assess data quality, and demonstrate increasing independence in statistical decision‑making
• Contribute to research projects and take initiative in professional activities
• Collaborate closely and participate in knowledge sharing with other statistical analysts
• Utilize various database management systems as required

Qualification requirements

Education requirements

Master’s degree in Biostatistics, Statistics, Bioinformatics, Mathematics or related field is required.

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 3 years of applied statistical experience is required.
• Experience programming in R for data manipulation and statistical analysis is required.
• Experience programming in SAS is required.
• Experience equivalent to 3 years working with complex longitudinal datasets and applying advanced statistical methods is preferred.
• Experience with causal inference theory and methods is a plus.

Knowledge, Skills, Abilities

• Highly organized and detail‑oriented, with excellent time management skills and the ability to prioritize tasks.
• Strong communication skills and the ability to work independently and as part of a team.
• Clear writing skills and adherence to best practices for commenting of programming code.

Location

Remote from home in the US! This role does not offer relocation benefits.

Legal and accommodation statements

• 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.
• 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.

Compensation and Benefits

The salary range estimated for this position based in Massachusetts is $80,000.00–$130,000.00.

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.

• 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

EEO 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.