Principal Biostatistician FSP, RWE

Job title: Principal Biostatistician FSP, RWE in Durham, NC at IQVIA
Company: IQVIA
Job description: Job Level: FSP Principal Biostatistician for RWE ResearchLocation: Home-based in the U.S. or CanadaWhy DSSS?Data Sciences Staffing Solutions, DSSS, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for an industry leading global CRO while collaborating with exert sponsor teams. These sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market.Job Summary: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.

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 (Minimal acceptable level of education, work experience, and competency)

• 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 standard

#LI-Remote#LI-NITINMAHAJANIQVIA 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. Learn more atIQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.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). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Expected salary:
Location: Durham, NC
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