Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 – To enable 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. As part of our clinical research portfolio, our CorEvitas evidence-based solutions specialize in generating data intelligence and clinical insights needed to bring safe and effective treatments to market. Your objectivity and dedication to patient safety will improve health outcomes that people and communities depend on – now and in the future.  
Location/Division Specific Information 
Remote, USA 
A key member of the CorEvitas Biostatistical Team, the Lead Biostatistician for Pharmacovigilance is the statistical team lead on many high-profile drug safety projects. This role is directly responsible for the success of specific statistical deliverables. The multifaceted role requires interaction with clients, various scientific resources, clinical principal investigators and project staff.  
#CorEvitas 
Discover Impactful Work: 
The Lead Biostatistician brings statistical expertise for studies evaluating drug safety.
The CorEvitas Biostatistics team at Thermo Fisher Scientific is comprised of three key focus areas: query work, pharmacovigilance (PV) work and registry coordination.  
•    With query work, we design, analyze and report on research projects, aka queries, with our clients to produce publications for the public domain (e.g. abstracts, posters, podium presentations, manuscripts, etc.).  
•    For our pharmacovigilance (PV) work we design studies, analyze data, and develop reports to provide real-world evidence regarding drug safety. Often our work is centered on long-term post authorization safety studies (PASS), and we partner with our pharma clients to support FDA, EMA, and other regulatory commitments.  
•    Within our registry coordination team, we work cross-functionally with the Engineering, Clinical Data Management and Project Management teams on all the registry data, taking into account client requests from our query and PV work. 
A day in the Life: 
•    Responsible for collaborating with investigators with diverse backgrounds to develop study protocols and statistical analysis plans (SAPs) that meet the requirements of the regulatory commitments
•    Independently performs sample size and power calculations for use in project development
•    Responsible for development and dissemination of final analytic reports to clients 
•    Leads client-facing conversations regarding study design and statistical aspects of safety-related research
•    Makes original contributions to research projects, takes initiative in professional activities and makes sound statistical decisions on an independent basis  
•    May oversee one or two members of the Biostatistical team (typically comprised of Biostatistician I/II/III) to complete the analyses detailed in the SAP, provide direction based on project requirements, and ensure accuracy and completeness of results and supporting documentation
•    Provide guidance and procedures to biostatistical group for data management and data integration 
•    Works collaboratively with various stakeholders to gain consensus across multi-functional groups 

•    Provides technical leadership and operational oversight to support Biostat PV data

•    Participation in a variety of weekly conference calls with clients, internal teams and senior Biostatistical staff 
•    Contribute and present published abstracts at research conferences and play a key role in published peer-reviewed manuscripts 
•    May train individuals within the department 
Keys to Success:  
Education 
Doctorate or Masters’ with appropriate experience level education in Biostatistics, Statistics or Mathematics (or equivalent) is required 

Experience 
•    Minimum 5-8 years of post-doctorate experience (for PhD) or comparable experience for Masters-level candidate in a research or medical setting 
•    Documented collaborative research experience with publications in peer-reviewed journals 
•    Demonstrated experience designing retrospective and prospective observational studies 
•    Has supervised and provided mentorship to junior biostatisticians

Knowledge, Skills, Abilities 
•    Knowledge of medical terminology and clinical epidemiology preferred 
•    Knowledge of causal inference theory and methodology a plus

•    Must be highly proficient in at least one of the following statistical packages: R (preferred), SAS and/or Stata  
•    Must be very familiar with complex, longitudinal data 
•    Strong interpersonal skills are required 
•    Demonstrated analytic skills to problem solve effectively 
•    Strong scientific, leadership and communications skills as well as a strict adherence to ethical business and research practices 
•    Must be able to make independent judgments under general supervision  
•    Must be highly organized and detail-oriented, with excellent time management skills and the ability to multi-task 

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 with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.  
Apply today!  
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. 
Accessibility/Disability Access 
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Job Tags

Remote job, Full time,

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