Epidemiologist / Real-World Data Associate

Epidemiologist / Real-World Data Associate

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Date: Sep 25, 2023

Location: CA

Company: Cytel Software Corporation

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development. In this role you will join our FSP department and will work for our clients, a growing biotech.

You will contribute by:

The Real World Data (RWD) Associate is accountable for overseeing the development, coordination and execution of cutting-edge, effective, and impactful epidemiology deliverables for their assigned registry. The RWD Associate will lead their assigned registry in project planning, management, and execution of epidemiology deliverables to ensure efficient and accurate completion within budget and timelines, and in accordance with current epidemiology and pharmacoepidemiology methodology. The RWD Associate is accountable for the execution of deliverables through oversight of Biostatistics and Programming resources and may be required to conduct ad hoc or feasibility analyses independently.

The RWD Associate will routinely interact with therapeutic area lead Epidemiologists within the department. The RWD Associate may participate in cross-functional Registry Leadership Teams and will lead sub-team meetings with Registry Biostatisticians and Programmers. The RWD Associate may work closely with registry stakeholders across Medical Affairs, Pharmacovigilance, Regulatory Affairs, and Clinical Development and must have mature team-working behaviors and organizational awareness and insight. The RWD Associate may also interact with external stakeholders to ensure appropriate communication of epidemiological issues and study results, including Scientific Advisory Board members and regulatory authorities.

Strong project planning, management, quantitative background, and execution ability, along with excellent communication skills, both written and oral are essential.

1. Propose, design, initiate, and report epidemiologic study analyses for their assigned Registry.

2. Responsible for coordinating work between Biostatistics and Stat Programming resources for planning/implementation of registry analytical deliverables.

3. Responsible for leading regularly scheduled team meetings with Biostatistics and Stats Programming. Ensure project timelines are maintained.

4. Responsible to review analysis plans, TLF shells, and TLFs. Prepare report summary and/or slides based on analytical project results (including SAB meeting slides)

5. Accountable to lead the project planning, management, and execution of epidemiology deliverables for their assigned Registry.

6. Provide epidemiology support to Medical Affairs, Pharmacovigilance, Regulatory Affairs, and Clinical Development related to their assigned Registry. Participate on cross-functional Registry Leadership Teams as appropriate. Lead sub-team meetings with Registry Biostatisticians and Programmers as appropriate.

7. Provide epidemiology perspective into study protocols, case report forms (CRFs), and regulatory documents and other reports for their assigned Registry.

8. May interact with authors, and in-house reviewers on scientific manuscripts, clinical conference abstracts, presentations, and posters based on data generated from their assigned Registry.

9. May participate with Epidemiology department during interactions with key external stakeholders including Registry Scientific Advisory Boards and regulatory authorities.

What we’re looking for:

• At least 3 years of experience, preferably in the pharmaceutical industry, biotechnology, or consulting environment for Doctoral-level candidates, or 6 years of industry experience for Master’s-level candidates.
• PhD / DSc / DrPH in Epidemiology, Biostatistics or related degree with 3 years of relevant experience, or
• MPH / MSc in Epidemiology, Biostatistics or related degree with 6 years of relevant experience
• Thorough and up-to-date technical knowledge of epidemiology and biostatistics methods
• Experience with study design, analysis planning and execution of analyses
• Strong project management skills and ability to prioritize multiple, competing projects
• Excellent oral and written communication skills
• Proficiency in using SAS for statistical analysis
• Excellent attention to detail and quality, and scientific rigor
• Ability to work under pressure in fast-paced environment and lead by example
• Strong interpersonal skills and ability to work effectively in multidisciplinary teams
• Record of high-quality publications in peer-reviewed journals
• Knowledge of drug and clinical development process preferred

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