Remote, NC, USA | Syneos Health
Industry:Healthcare - Hospitals
Job Description:58 people have viewed this job
Director Epidemiology, RWE is responsible for scientific management and oversight of prospective non-interventional clinical studies, observational research studies, and retrospective real world data analysis and evidence generation. Leads study design, provides methodologic expertise, reports results and disseminates study findings under the direction of the study sponsor. Other responsibilities include feasibility assessment, providing business development support for Real World and Late Phase (RWLP), and producing high quality RWE research and raising awareness of RWE.
- Oversee the scientific aspects of study start-up and ongoing study management, including but not limited to the development of study protocols and other key study documents (survey, interview guide, case report forms, informed consent form, training materials, statistical analysis plan, study management plans, etc.).
- Conducts and/or provides critical review and oversight of statistical analyses.
- Facilitates scientific advisory boards for safety studies and produces scientific study reports/manuscripts/abstracts/posters/presentations.
- Maintains a strong working understanding of clinical and epidemiological practice guidelines, clinical research models, protocol designs, real-world research development trends, and regulatory expectations for non-interventional and observational research.
- Provides overall scientific oversight of selected projects, responsible for meeting or exceeding customer expectations for timelines, budgets, quality, and overall satisfaction.
- Provides strategic input from a scientific perspective as a member of the RWLP team; builds organizational capacity, improvement of scientific and operational processes and real-world research methodologies, and RWLP Standard Operating Procedures (SOP) development and maintenance.
- Works with RWLP management, business development, and operations personnel to develop and win global business opportunities; provides input into feasibility analysis to determine whether a study of the client’s issue/problem is feasible; proposes the study design; provides input into the proposal and budget; helps to develop and deliver bid defenses and capabilities presentations.
- Develops abstracts, provides podium presentations, and leads authorship of articles, manuscripts, etc. in industry and peer-reviewed journals to promote Company services.
- Requires advanced degree in Epidemiology, Statistics, Health Economics or Public Health; (Masters with 8+ years; Preferred Doctorate with 6+ years);
- Requires in-depth knowledge of and experience with a variety of study designs; familiarity with post-marketing and late phase study designs as well as relevant guidelines preferred;
- Requires basic knowledge of statistical programming language(s) (e.g., SAS, R, Python);
- Excellent communication, presentation, both written and spoken;
- Must have extensive experience with personal computers and MS Office suite (Word, Excel, PowerPoint, Outlook);
- Above average attention to detail, accuracy and organization;
- Ability to perform several tasks simultaneously to meet deadlines;
- Strong personal communication and team-oriented skills;
- Demonstrated leadership and technical skills.
- As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.
This job excludes CO applicants.
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