Biostatistician II, Pharmacovigilance Focus- Fully remote!

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? 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. With query work we design, analyze, and report on research projects, i.e. queries, with our clients to produce publications for the public domain (e.g. abstracts, posters, podium presentations, manuscripts, etc.) 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. A day in the Life of a Biostatistician II within this team: 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 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 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. 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 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 Location: Remote from home in the US! This role does not offer relocation benefits.

• 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not d Apply tot his job Apply To this Job