Lead Biostatistician

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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 lifechanging therapies. As part of our clinical research portfolio our CorEvitas evidencebased 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 highprofile 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 realworld evidence regarding drug safety. Often our work is centered on longterm 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 crossfunctionally 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 clientfacing conversations regarding study design and statistical aspects of safetyrelated 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 multifunctional 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 peerreviewed 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 58 years of postdoctorate experience (for PhD) or comparable experience for Masterslevel candidate in a research or medical setting
Documented collaborative research experience with publications in peerreviewed 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 detailoriented with excellent time management skills and the ability to multitask


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 100000 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.
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