Biostatistician II, Pharmacovigilance Focus- Fully remote!

Thermo Fisher Scientific • Waltham, MA

1d • Remote

About The Position

At Thermo Fisher Scientific, the Biostatistician II will engage in meaningful work that positively impacts global health by enabling customers to make the world healthier, cleaner, and safer. The company supports individual career goals and advances science through research, development, and delivery of life-changing therapies, conducting clinical trials in over 100 countries. This role is crucial for improving health outcomes through quality and accuracy.

The Biostatistician II will operate under the guidance of a Biostatistical Team Lead, focusing on implementing statistical analysis plans for complex longitudinal registry data, particularly in autoimmune disease areas. The role involves preparing analytic summaries and context for reports and publications.

The CorEvitas Biostatistics team at Thermo Fisher Scientific is structured around three main areas: query work, pharmacovigilance, and registry coordination. In pharmacovigilance, the team designs studies, analyzes data, and develops reports to generate real-world evidence on drug safety. This includes partnering with pharmaceutical clients to conduct long-term post-authorization safety studies to fulfill regulatory commitments from bodies like the FDA and EMA. The registry coordination aspect involves cross-functional collaboration with Engineering, Clinical Data Management, and Project Management teams to manage registry data and integrate client requests from query and pharmacovigilance work.

Requirements

• Master's degree in Biostatistics, Statistics, Bioinformatics, Mathematics or related field is required (or an equivalency consisting of a combination of appropriate education, training and/or directly related experience)
• A 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
• Must be highly organized and detail-oriented, with excellent time management skills and the ability to prioritize tasks
• Must possess strong communication skills and be able to work independently and as part of a team
• Requires clear writing skills and must follow best practices for commenting of programming code
• 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

• Experience equivalent to 3 years working with complex longitudinal datasets and applying advanced statistical methods
• Experience with causal inference theory and methods

Responsibilities

• Implement statistical analysis plans involving complex longitudinal registry data available in several autoimmune disease areas
• Help to prepare appropriate analytic summaries and context for reports and publications
• 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
• Closely collaborate and participate in knowledge sharing with other statistical analysts
• Utilize various database management systems as required
• Design, analyze, and report on research projects (queries) with clients to produce publications for the public domain (e.g., abstracts, posters, podium presentations, manuscripts)
• Design studies, analyze data, and develop reports to provide real-world evidence regarding drug safety for pharmacovigilance work
• Partner with pharma clients to conduct long-term post-authorization safety studies to support FDA, EMA, or other regulatory commitments
• Work cross-functionally with the Engineering, Clinical Data Management, and Project Management teams on all registry data, while incorporating client requests from the query and PV work

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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level