Clinical Data Scientist/ Methodologist
BioSpace · Bridgewater, NJ · 2 wk ago
HybridInformation TechnologyFull-time
About the role
Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization.
The Data Assessment Center of Excellence (CoE) is a specialized team within Sanofi's Digital RWD & HI function, operating at the intersection of epidemiology, RWD, data products and insights/evidence generation. The vision of the CoE is to ensure all Sanofians have the right data, used the right way, for real patient impact.
Main Responsibilities
- Lead and execute feasibility assessments for RWD sources (electronic health records, administrative claims, patient registries, wearable/digital health data) to determine suitability for specific research/business objectives
- Develop and apply structured data assessment frameworks to evaluate data quality dimensions, including accuracy, completeness, validity, timeliness, longitudinally consistency, and integrity
- Assess the availability and representativeness of patient populations within RWD sources available in Sanofi for both internal decision-making and regulatory-grade evidence generation
- Evaluate the feasibility of extracting structured and unstructured data elements (e.g., clinical scores, patient-reported outcomes) from EHR systems, including NLP-based extraction from clinical notes
- Document assessment outcomes in standardized feasibility reports and communicate findings clearly to cross-functional stakeholders
- Identify and articulate limitations of RWD sources, such as proxy endpoint constraints, population coverage gaps
- Design methodologically sound recommendations & minimize misuse of RWD, leading to unreliable insights or evidence generation
- Ensure appropriate use of ICD codes, procedure codes, and other medical coding standards (sourced from peer-reviewed references such as PubMed, Embase, and Orphanet, etc.) for patient identification, healthcare provider segmentation, clinical site identification, and phenotyping
- Apply advanced epidemiological and biostatistical methods including propensity score methods, time-to-event analyses, sensitivity analyses, and bias assessment
- Provide methodological input on the use of clinical score proxies and surrogate endpoints in RWD contexts, clearly delineating their applicability for internal versus regulatory/publication use
- Provide methodology advises ensuring deliverables from RWD Foundation, RWD Science, and RWD Products are based on medical evidence/guidelines, clinically & contextually relevant
- Work closely with analysts & data scientists to ensure methodological recommendation is realistic and implementable
- Partner with R&D, Business units (Vaccines, General Medicine and Specialty Care) & Digital teams on data identification and appropriate usage of RWD for insights / evidence generation across drug lifecycle
- Serve as the methodological point of contact for fit-for-purpose data assessment inquiries from internal stakeholders
- Collaborate with RWD Foundation, RWD Product Owners, RWD Data Sciences to ensure RWD are used appropriately to inform reliable decision making & to provide knowledge transfer on data domain expertise
- Manage external data vendors and technology partners (e.g., EHR, claims, registries) to understand data limitations and to verify methodological recommendations when required
About You
- Advanced degree (Master's or PhD) in Epidemiology, Biostatistics, Health Informatics, Health Economics, Pharmacoepidemiology, or a closely related quantitative discipline
- Minimum 4-5 years for Masters degree holder or 2-4 years for Doctoral degree holder of relevant experience in real-world data, commercial analytics, real-world evidence, health outcomes research, fit-for-purpose feasibility assessment, data quality assessment or a related field within the pharmaceutical, biotech, or health technology industry
- Experience in predictive modeling using RWD to identify at risk patient populations with a publication record in peer-review journals
- Experience in patient & healthcare provider segmentation to inform Medical and Commercial strategy
- Demonstrated expertise in epidemiological study design and statistical methods such as propensity score matching, descriptive statistics, regression analysis, predictive modelling
- Strong proficiency in statistical programming languages: SQL, Python, R, and/or SAS
- Solid working knowledge of Snowflake for database querying and data extraction
- Familiarity with medical coding systems: ICD-10, CPT, SNOMED CT, LOINC, RxNorm and experience/knowledge on OHDSI OMOP CDM standardized data model for healthcare data
- Understanding of US EHR, claims, disease registry data, public health surveillance data as well as US healthcare billing system
- Experience with AI coding tools such as Cursor, GitHub Copilot, Claude, LLM
- Knowledge of automation tools such as Power Automate, Power App (an asset not required)
- Requires a high level of interactive communication with diverse stakeholders
- Can work with assumptions & in a fast-paced environment
- Proven teamwork and collaboration skills