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 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 Job Seekers with a

Disability:

Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255•. Please include your contact information and specific details about your required accommodation to support you during the job application process. •This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response. 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. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: 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 For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. 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. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.