Biostatistician II, Pharmacovigilance Focus- Fully remote!

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. 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. The CorEvitas Biostatistics team at Thermo Fisher Scientific is comprised of three key focus areas: query work, pharmacovigilance, and registry coordination. For our pharmacovigilance work we design studies, analyze data, and develop reports to provide real-world evidence regarding drug safety. We partner with our pharma clients to conduct long-term post-authorization safety studies to support FDA, EMA, or other regulatory commitments. Within our registry coordination team, we 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.

Responsibilities

• Compiles, analyzes, and reports statistical data for various projects
• Conducts complex statistical analyses with supervision in accordance with statistical analysis plans
• Supports the Biostatistical Team Lead in developing new statistical methodologies for data analysis
• Applies advanced statistical methods, which may include simulation models and other statistical programming, as needed
• Reviews relevant literature and existing data, assesses data quality, and demonstrates increasing independence in statistical decision-making
• Contributes to research projects and takes initiative in professional activities
• Closely collaborates and participates in knowledge sharing with other statistical analysts
• Utilizes various database management systems as required

Requirements

• Master's degree in Biostatistics, Statistics, Bioinformatics, Mathematics or related field is required
• 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 is preferred
• Experience with causal inference theory and methods is a plus

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

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