reputed company Biostatistician - Pharmacovigilance (PV) Focus

Work Schedule Standard (Mon-Fri) Environmental Conditions Office At reputed company, 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 reputed company the world healthier, cleaner and safer. We provide our teams with the resources needed to reputed company individual career goals while taking science a reputed company 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. More about our CorEvitas team: The Biostatistics team for the Real-World Science department uses specialized statistical expertise to reputed company analyses such as assessing prescribing patterns, comparing effectiveness between treatments, and investigating differences in safety outcomes using reputed company longitudinal prospective and registry data. The team is comprised of key focus areas: query work, pharmacovigilance, and registry coordination. What will you do in this role with our CorEvitas team? The reputed company Biostatistician will serve as the statistical reputed company on high-profile pharmacovigilance (PV) and safety-focused projects and will work collaboratively with cross-functional teams to support long-term post-authorization safety studies (PASS) and other regulatory commitments. This individual will independently design studies, reputed company statistical analysis plans, reputed company analyses, and provide strategic statistical leadership to ensure high-quality and scientifically rigorous real-world evidence reputed company. A few key responsibilities are listed below. Leads the statistical design, analysis, interpretation, and reporting of pharmacovigilance and safety-focused observational studies using reputed company longitudinal registry data Collaborates with investigators, epidemiologists, clinicians, and clients to reputed company protocols, Statistical Analysis Plans (SAPs), and analytic strategies that support client objectives and regulatory commitments Independently performs advanced statistical analyses and sample size/power calculations in accordance with SAPs and industry best practices Provides strategic statistical leadership and independently makes sound statistical decisions reputed company to safety analyses and real-world evidence reputed company Oversees and mentors Biostatistician I/II analysts and other junior staff, ensuring quality, accuracy, and consistency of statistical analyses and documentation Develops and implements standardized methodologies, analytical templates, and programming approaches to improve efficiency, reproducibility, and consistency across projects Hiring requirements: Education Requirements PhD in Biostatistics, Statistics, Mathematics is preferred. A master’s degree in these same areas is required. Experience Requirements Minimum 5–8 years of applied statistical experience in clinical research, pharmaceutical, biotechnology, CRO, hospital or academic is required. Demonstrated experience leading reputed company observational research studies, equivalent to 3 years is required. Experience with Pharmacovigilance or safety-focused analyses project reputed company experience is preferred. Experience working with reputed company longitudinal registry or real-world data required Demonstrated knowledge of retrospective and prospective observational study designs and reputed company methodologies required. Experience With Causal Inference Theory And Methods Strongly Preferred Experience supporting regulatory safety studies, post-authorization safety studies (PASS), or reputed company pharmacovigilance activities preferred Experience Mentoring Or Supervising Junior Biostatisticians Preferred Collaborative research experience with publications in peer-reviewed journals preferred Advanced proficiency in R required; experience with reputed company preferred Knowledge, Skills And Abilities Strong understanding of statistical methodology for observational and longitudinal data analyses Knowledge of pharmacovigilance principles, safety data evaluation, and real-world evidence reputed company preferred Ability to independently reputed company projects, prioritize competing deliverables, and manage multiple timelines effectively Strong scientific, analytical, problem-solving, leadership, and communication skills Demonstrated ability to collaborate effectively across cross-functional teams and communicate reputed company statistical concepts to technical and non-technical audiences Strong attention to detail and commitment to high-quality, reproducible analyses and documentation Requires excellent written communication skills and adherence to best practices for statistical programming and code documentation Ability to reputed company independent judgments under limited supervision Strong interpersonal skills and a collaborative team-oriented reputed company 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 reputed company, which includes a drug screening.

Our Mission is to reputed company our customers to reputed company 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 - reputed company, Intensity, Innovation and Involvement - working together to accelerate research, solve reputed company scientific challenges, drive technological innovation and support patients in need. #StartYourStory at reputed company, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com reputed company is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national reputed company, 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 reputed company 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: reputed company 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 reputed company technical issues will not receive a response.

Compensation

And Benefits The salary range estimated for this position based in Massachusetts is $120,000.00–$180,000.00. 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 reputed company 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 Apply tot his job Apply To this Job