Senior Research Scientist- RWE/Harm Reduction

Responsibilities

• Be the Principal Investigator, lead the design of behavioral studies (e.g., Actual Use, PMSS, TPPI) including writing research proposals, collaborating on protocol and statistical analysis plan (SAP) development, overseeing data analysis, providing analytical interpretation, writing reports, abstracts, posters, and manuscripts.
• Successfully lead engagements to ensure client satisfaction and ensure deliverables are sent on time and are of rigorous scientific quality.
• Monitor evolving FDA guidance and behavioral science methodologies to inform regulatory strategy and study design.
• Present at professional conferences.

Qualifications

• Minimum a MPH or Master’s with 5+ years of industry experience or PhD with 5 years of independent research experience - any advanced degree in epidemiology, public health, or related discipline.
• Strong scientific writing and presentation skills for client engagement.
• Knowledge of and experience working with statistics including regression techniques (OLS, logistic regression, generalized linear models), mixed models (e.g., survival and longitudinal analysis), non-parametric approaches, and data reduction techniques (e.g., factor analysis, SEM).
• Must have a strong publication history with multiple peer-reviewed manuscripts.
• Knowledge of CDISC SDTM and ADaM standards.
• Experience with PMTA-specific studies preferred, such as Actual Use studies (AUS), Tobacco Product Perception and Intention (TPPI) or Post Market Surveillance studies (PMSS).
• Excellent oral and written communication skills.
• Ability to multitask several projects in a fast-paced environment.
• Proficiency in MS PowerPoint, MS Excel, MS Word. R or SAS a plus.