Principal Biostatistician FSP, RWE

IQVIA LLC; Durham (NC); Remote; USD 131,000 - 244,000; Full time

Job summary

An established industry player is seeking a Principal Biostatistician to provide statistical support for drug development using Real World Evidence (RWE). In this pivotal role, you will collaborate with multi-disciplinary teams, lead the design and conduct of observational research, and ensure the quality and consistency of analytics deliverables. Your expertise in statistical methodologies and RWE will be crucial in supporting regulatory approvals and payer engagements. This position offers a unique opportunity to impact patient outcomes while working with innovative medical treatments in a flexible, remote environment.

Qualifications

• PhD or MS in Statistics/Biostatistics with relevant industry experience.
• Expertise in RWE methodologies and statistical analysis.

Responsibilities

• Lead statistical support for drug development based on RWE.
• Develop study protocols and statistical analysis plans.

Skills

Statistical analysis

Real World Evidence (RWE)

Data analysis

Project management

Statistical software (SAS, R)

Communication skills

Education

PhD in Statistics or Biostatistics

MS in Statistics or Biostatistics

Tools

SAS

R

Job description

Principal Biostatistician FSP, RWE

Job Summary

The Principal Biostatistician is responsible for providing full range statistical support for drug development based on real world evidence (RWE).

Job Requirements

• 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 the statistical sections of clinical trial protocols, while consulting with internal and external experts.
• 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 study designs.
• 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.
• Ensures quality and consistency of analytics deliverables.
• 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 RWE.
• Collaborates with and manages vendors to ensure project timelines and goals are met.
• Participates in other activities and meetings to support Biostatistics and the Development Team as needed.

Qualifications

• 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 with different applications of RWE, including in support of early-stage clinical development, regulatory approvals, and payer/HTA/provider engagements.
• Knowledge of global regulatory and HTA requirements for RWE.
• Demonstrated ability in evaluation and development of RWE from conceptualization through application.
• Experience leading the design and conduct of observational research, including protocol, statistical analysis plan, and study report development.
• Extensive working experience with stakeholders such as medical affairs and health economics.
• Hands-on experience with prospective and retrospective observational studies.
• Experience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries.
• Excellent organizational skills and proven ability to effectively lead multiple projects to successful completion.
• High level of competency using standard statistical software such as SAS or R.
• 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 standards.

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

The potential base pay range for this role, when annualized, is $131,300.00 - $243,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).