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Company

Original Job Post

myGwork - LGBTQ+ Business Community · 3 days ago

Senior Research Scientist

North Carolina, United States

Full-time

Remote

Senior Level

15+ years exp

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Responsibilities

Serve as the responsible person for strategic consultation, client insights, and consultative selling.

Define best methods to address research needs and partner with research operations leadership.

Ensure flawless project execution by providing senior oversight of project design, protocol, and final study report development.

Develop innovative Real-World Evidence solution-focused offerings.

Contribute to internal and external thought leadership.

Provide scientific oversight of RWE/non-interventional study methods and ensure the quality and timeliness of scientific deliverables.

Mentor mid-level and junior staff and serve as a subject matter expert in RWE, medical affairs, and epidemiology or biostatistics.

Contribute to abstracts and manuscripts, make presentations at scientific meetings, and manage externally facing multi-stakeholder engagements.

Participate in business development activities, proposals, and identify new projects.

Qualification

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Pregnancy ExperienceSafetyMedical AffairsClinical DevelopmentMedical Device DevelopmentHEOREpidemiologyRWEEpidemiological Study MethodologyBiostatisticsQuantitative MethodsMS OfficeSAS/STATAStatistical Analysis SoftwareProblem-SolvingCommunicationPresentationRWE ExpertiseEngagement

Required

PhD in Epidemiology, Masters in Epidemiology is required with at least 15 years' relevant expertise and experience

Pregnancy Experience Is Required Post-marketing experience

Safety experience

Medical affairs

Clinical development in biopharma/biotech (especially peri- or post-approval late phase interventional studies)

Medical device development (in-vitro diagnostics, SaaMD)

Post-authorization drug/device safety, effectiveness, long-term follow-up

HEOR/epidemiology/RWE

8+ years' management experience

Knowledge of drug development process/familiarity with international regulatory requirements for drugs and devices in both pre- and post-authorization context

In depth expertise on regulatory requirements for pregnancy and lactation studies

Excellent understanding of core epidemiological study methodology and/or biostatistics

Broad experience in quantitative methods in life-sciences research, focus on design and implementation of non-interventional and/or interventional studies

Working knowledge of MS Office software; ability to read and understand SAS/STATA output; working knowledge of statistical analysis software (e.g., SAS, Stata, R) is a plus

Analyzes complex issues and evidence, identify cause-effect relationships, and generate effective solutions

Experience presenting ideas to individuals and groups in a formal presentation setting

Tailors and delivers high-level presentations to diverse audiences using a variety of communication delivery methods (e.g., written, electronic, oral, interpersonal)