Principal Biostatistician FSP, RWE

IQVIA • Durham, NC

238d • $131,300 - $243,900 • Remote

About The Position

The Principal Biostatistician is responsible for providing full range statistical support for drug development based on real world evidence (RWE). This role involves collaborating with multi-disciplinary project teams to establish project goals and timelines, serving as the statistical lead on health outcomes and epidemiology studies, and acting as a subject matter expert for RWE/HEOR/HTA research design, methodologies, data sources, analytic techniques, and reporting. The position also includes writing statistical analysis plans, providing strategic and tactical support for cross-functional RWE development for regulators, payers, and clinicians, and leveraging various real-world data sources to recommend optimal analysis methods.

Requirements

• PhD in Statistics, Biostatistics, or related field with 5+ years industry experience, or MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
• 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.
• Ability to execute statistical analysis plans using advanced programming techniques.
• Ability to effectively interpret and communicate research results.
• Understanding of ICH GCP and E9 as well as general knowledge of industry practices and standards.
• Knowledge of global regulatory and HTA requirements for RWE.

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.
• Serve as statistical lead and represent Biometrics on health outcomes and epidemiology studies.
• Act as subject matter expert for RWE/HEOR/HTA research design, methodologies, data sources, analytic techniques, and reporting.
• Write statistical analysis plans.
• Provide strategic and tactical support for cross-functional RWE development for regulators, payers, and clinicians.
• Leverage administrative claims, electronic medical records, registries, or other real-world data and recommend optimal analysis.
• Select and implement appropriate analytical methods including statistical models or machine learning models.
• Develop high quality study protocols, statistical analysis plans, study reports, and other study documents.
• Identify innovation opportunities for the use of RWD.
• Establish effective communication with various internal stakeholders.
• Maintain the highest standards of data accuracy and integrity.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Ph.D. or professional degree