Principal Biostatistician FSP, RWE at IQVIA

Durham, North Carolina, United States

IQVIA Logo
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

  • 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
  • Serve 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 to align with overall business objectives
  • 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 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
  • 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 regulatory guidelines and requirements

Responsibilities

  • Develops and implements RWE strategies
  • Provides statistical expertise for RWE/HEOR/HTA research
  • Supports regulatory submissions related to RWE
  • Works with various internal stakeholders to understand and support RWD utilization
  • Ensures data accuracy and integrity

Skills

Biostatistics
RWE
HEOR
HTA
Statistical Analysis Plans
Statistical Modeling
Machine Learning
Real-World Data
Administrative Claims
Electronic Medical Records
Registries
Study Protocols

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters
1998Year Founded
$3,526MTotal Funding
POST_IPO_EQUITYCompany Stage
Cybersecurity, Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.
Proliferation of disparate technological solutions causes technology overload in clinical trials.
Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.
The company offers privacy-enhancing technologies to protect individual patient data.
IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.
AI-driven drug discovery accelerates identification of potential drug candidates.
Expansion of telemedicine facilitates remote patient monitoring and data collection.

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