FSP Principal Biostatistician - RWE in Neuroscience

$131,300 - $243,900/Yr

Quintiles - Bloomington, IL

Part-time - Principal

Remote - Bloomington, IL

Ambulatory Health Care Services

About the position

The Principal Biostatistician is responsible for providing statistical support for drug development based on real-world evidence (RWE). This role involves collaborating with multi-disciplinary project teams, serving as a statistical lead, and acting as a subject matter expert in RWE/HEOR research design and methodologies. The position offers opportunities for technical training, career development, and a focus on bringing new therapies to market.

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 a subject matter expert for RWE/HEOR research design, methodologies, data sources, analytic techniques, and reporting.
• Write the statistical sections of clinical trial protocols, consulting with internal and external experts.
• Provide strategic and tactical support for cross-functional RWE development for regulators, payers, and clinicians.
• Leverage administrative claims, electronic medical records, or other real-world data and recommend optimal study designs.
• Select and implement appropriate analytical methods including statistical models or machine learning models to align with overall business objectives.
• Develop high quality study protocols, statistical analysis plans, study reports, and other study documents.
• Ensure quality and consistency of analytics deliverables.
• Identify innovation opportunities for the use of RWD.
• Establish effective communication with various internal stakeholders to understand and support the strategy for when and how to use RWE.
• Collaborate with and manage vendors to ensure project timelines and goals are met.
• Participate in other activities and meetings to support Biostatistics and the Development Team as needed.

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.
• 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.

Benefits

• Home-based remote working opportunities
• Work/life balance and 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 with long-term engagements and re-deployment opportunities
• Focus on bringing new therapies to market rather than project budgets and change orders
• Engaging, fast-paced environment
• Good work-life balance