Remote Research assistant Jobs in Durham, NC

Essential Functions) :

The SRS bears responsibility for scientific strategy for RWE, medical affairs, and certain clinical studies, including the leading of the overall research strategy development for proposals, the design and implementation of de novo data collection and diversified data design studies, as well as internal and external thought leadership. In particular, the SRS will :

Scientific strategy consulting

Be the responsible person for early client-facing interactions and development of strategies to maximize the potential for winning project work related to pregnancy and lactation studies through scientific consulting.

Understand the regulatory context for RWE specifically related to pregnancy and lactation studies in key geographies and be able to advise clients to pursue the most plausible RWE strategies.

Maintain current and in-depth understanding of the overall RWE landscape and provide leadership with ongoing recommendations for positioning the team and offerings.

Collaborate on the development of innovative RWE solution-focused offerings

Senior scientific oversight of studies.

Be the responsible person for the design and implementation of selected.

RWE / non-interventional study methods, conceptualize advanced study designs and develop / oversee the development of study protocols and statistical analysis plans and study reports; focus will primarily be on the pregnancy and lactation studies with a particular emphasis on safety, but will also provide scientific oversight on other study designs.

Be responsible for the quality on-time completion of scientific deliverables; ensure study findings are valid and reliable.

Responsible for final budget, deliverable and project timelines; identify scope expansion and need for amendments, as needed.

Oversee and delegate tasks to mid-level staff.

Internal thought leadership.

Serve as consultant to other principal investigators or staff on other projects.

Contribute to / lead growth in your area of responsibility.

Serve as a subject matter expert in RWE, medical affairs, and epidemiology or biostatistics to the broader PPD organization.

Mentor mid-level and junior staff.

External thought leadership.

Contribute to abstracts and manuscripts as co-author and when possible, first / senior author positions.

Make presentations at scientific meetings.

Contribute to Evidera’s position as a recognized leader in RWE generation and integration.

Contribute to the development and manage externally facing multi-stakeholder engagements.

Business development

Direct other "non-billable" activities, participate in proposals, design conceptual approaches for proposals, supervise mid-level staff, contribute to business development, identify and pursue business opportunities within Evidera and bring in new projects

Travel (national and international) is expected

Consulting Expectations

Participates in client calls; addresses questions posed directly to him / her about his / her work.

Responsible for scientific consultation and for use of best scientific methods to address research needs.

Contributes to strategic thinking and innovation.

Education, Professional Skills & Experience

PhD in Epidemiology, Masters in Epidemiology is required with at least 15 years’ relevant expertise and experience in at least one (and preferably more) of the following key areas :

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

In depth expertise and engagement in current global discourse around regulatory use of RWE is highly desirable

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 (, 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 (, written, electronic, oral, interpersonal)

Benefits :

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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 PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.