Senior Research Scientist

About the Role

Oracle Life Sciences is seeking a qualified health outcomes researcher with a Master’s or PhD to join our Real World Evidence Tobacco Harm Reduction team. As a Senior Research Scientist, you will lead the design, analysis, and reporting of regulatory studies that meet the scientific rigor required for FDA CTP submissions. This role demands a strategic thinker with strong research, writing, and communication skills, providing essential research consultation to both internal and external clients.

We are looking for a strategic leader to design, execute, and interpret behavioral research supporting regulatory submissions, including PMTAs. The ideal candidate will bring deep expertise in behavioral science, regulatory strategy, and cross-functional collaboration, ensuring all data adheres to FDA requirements.

Responsibilities

• Be the Principal Investigator, leading 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, and writing reports, abstracts, posters, and manuscripts.
• Successfully lead engagements to ensure client satisfaction and deliver rigorous scientific quality on time.
• Monitor evolving FDA guidance and behavioral science methodologies to inform regulatory strategy and study design.
• Present findings at professional conferences.
• Be available for travel to support all responsibilities.

Required Qualifications

• Minimum of an MPH or Master’s with 5+ years of industry experience, or a PhD with 5 years of independent research experience, in epidemiology, public health, or a related discipline.
• Must have experience in survey design and quantitative methods.
• 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 proficiency is a plus.

About Oracle

Only Oracle brings together the data, infrastructure, applications, and expertise to power everything from industry innovations to life-saving care. With AI embedded across our products and services, we help customers turn that promise into a better future for all. Discover your potential at a company leading the way in AI and cloud solutions that impact billions of lives.

Oracle is committed to growing a workforce that promotes opportunities for all with competitive benefits that support our people with flexible medical, life insurance, and retirement options. We encourage employees to give back to their communities through our volunteer programs. Oracle is an Equal Employment Opportunity Employer.

Benefits

• Medical, dental, and vision insurance, including expert medical opinion.
• Short term disability and long term disability, Life insurance and AD&D, Supplemental life insurance (Employee/Spouse/Child).
• Health care and dependent care Flexible Spending Accounts, Pre-tax commuter and parking benefits.
• 401(k) Savings and Investment Plan with company match.
• Paid time off: Flexible Vacation for salaried employees; Accrued Vacation (13-18 days annually) for others. 11 paid holidays.
• Paid sick leave: 72 hours upon hire, refreshes annually (cap 112 hours).
• Paid parental leave, Adoption assistance.
• Employee Stock Purchase Plan, Financial planning and group legal.
• Voluntary benefits including auto, homeowner, and pet insurance.

Key skills/competency

• Real World Evidence (RWE)
• Regulatory Strategy
• Behavioral Science
• FDA Submissions
• Quantitative Methods
• Survey Design
• Epidemiology
• Scientific Writing
• Statistical Analysis
• Project Leadership