Principal Biostatistician FSP, RWE

IQVIA•Durham, NC

10d•Remote

About The Position

The Principal Biostatistician is responsible for providing full range statistical support for drug development based on real world evidence (RWE). Additional Benefits: Home-based remote working opportunities Work/life balance as well as flexible schedules. Collaborating with motivated, high-performance, statistical and research teams Technical training and tailored development curriculum Research opportunities that match your unique skillset Promising career trajectory Job stability: long-term engagements and re-deployment opportunities Focus on bringing new therapies to market rather than project budgets and change orders. Experience with regulatory submissions. Engaging, fast-paced environment. Good work-life balance.

Requirements

In-depth knowledge of RWE databases, including large administrative claims data, EMR, disease registries, and clinical trial data.
Demonstrated ability in evaluation and development of RWE from conceptualization through application.
Familiarity with LOINC codes, reimbursement and lab data interpretation, and ability to implement surrogate variable algorithms (e.g., phenotype definitions, proxies for clinical endpoints)
Ability to execute statistical analysis plans using advanced programming techniques to perform detailed and complex analyses relevant to real-world evidence.
Ability to effectively interpret and communicate research results to internal and external audiences.
Understanding of ICH GCP and E9 as well as general knowledge of industry practices and standard
Knowledge of global regulatory and HTA requirements for RWE
PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.
MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
Experience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries.
Solid hands-on experience as Project statistician with real-world data , including EMR/EHR and claims datasets (e.g., Humedica, Optum, MarketScan, CMS, Komodo, Truveta, TrinetX, etc.); Fluency in making LOA, mock TFLs, protocol and SAP
Experience in cost analysis and healthcare resource utilization (HCRU) evaluation using RWD
Excellent organizational skills and proven ability to effectively lead multiple projects to successful completion.
SME-level proficiency in SAS programming tailored to handle complex inclusion and exclusion criteria, conduct propensity score matching, and develop outcome metrics.
Expertise in R is also valued.
Experience with CDISC ADAM datasets.
Extensive working experience with stakeholders such as medical affairs and health economics

Nice To Haves

Understanding of payer landscape , health economic outcomes, and value demonstration frameworks
Exposure to regulatory submissions , HTA support.

Responsibilities

Collaborate with multi-disciplinary project teams to establish project goals and timelines.
Serves as statistical lead and represents Biometrics on health outcomes and epidemiology studies.
Serves as subject matter expert for RWE/HEOR/HTA research design, methodologies, data sources, analytic techniques, and reporting.
Writes statistical analysis plans.
Provides strategic and tactical support for cross-functional RWE development for regulators, payers, and clinicians.
Leverages administrative claims, electronic medical records, registries, or other real-world data and recommends optimal analysis.
Selects and implements appropriate analytical methods including statistical models or machine learning models to align with overall business objectives.
Develops high quality study protocols, statistical analysis plans, study reports, and other study documents.
Identifies innovation opportunities for the use of RWD.
Establishes effective communication with various internal stakeholders to understand and support the strategy for when and how to use RWD.
Commitment to maintaining the highest standards of data accuracy and integrity by implementing rigorous quality control processes throughout the data handling and analysis phases.
Demonstrated ability to quickly adapt to new requirements and efficiently handle ad-hoc requests.

Benefits

Home-based remote working opportunities
Work/life balance as well as flexible schedules.
Collaborating with motivated, high-performance, statistical and research teams
Technical training and tailored development curriculum
Research opportunities that match your unique skillset
Promising career trajectory
Job stability: long-term engagements and re-deployment opportunities
Focus on bringing new therapies to market rather than project budgets and change orders.
Experience with regulatory submissions.
Engaging, fast-paced environment.
Good work-life balance.