Senior Director / Director Biostatistical Science: Novel Trial Designs
IQVIA Holdings Inc.
Durham, North Carolina
IQVIA is changing an entire industry through inspired innovation. Our People make the difference. We believe that great ideas can come from anywhere. Great products come from great ideas. And great ideas come from great people. We look for the very best people and then give them meaningful work to do. Join IQVIA and help us make the world a better place.
Job Profile Summary
This senior scientist will be responsible for strategic biostatistical input on innovative trial opportunities (such as, for example, adaptive approaches generally, and Bayesian approaches specifically) from both the design, methodological and regulatory perspectives.
- Provide strategic biostatistical input with special focus on innovative methods, to high priority sales opportunities to help increase revenue, with emphasis on methods to cut costs, decrease time, or increase chance of success for drugs development by pharmaceutical companies both at the CDP and individual trial level.
- Represent IQVIA and its Clients at FDA and EMEA meetings
- Perform statistical and mathematical modeling and decision analysis
- Market IQVIA strategic and innovative statistical science expertise, that may include: (i) publishing papers; (ii) giving presentations at conferences; (iii) and publicizing internally to key groups.
- Maintain knowledge and awareness--internally and externally--of innovations in statistical science, clinical trial methodology, and regulatory requirements that impact design.
- Participate in the provision of training on advanced statistical topics or advanced case studies.
- Participate in the provision of high-level statistical science consultancy clients and IQVIA staff.
- Support software development in adaptive designs, and master protocols.
- Support development of new adaptive designs, and related statistical science methods.
Minimum Required Education and Experience
To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the Responsibilities.
Typically requires a minimum of 7+ years of prior relevant experience. Direct experience working with regulators, especially the FDA, is preferred.
Requires exceptional domain and business knowledge to drive results for the organization.
Applies extensive business and industry expertise and provides organizational thought leadership.
Advanced degree in Biostatistics or related discipline.
Additional Work Experience
7+ years of experience working on clinical trials with 5+ years of experience in a leadership capacity supporting clients and new business or equivalent combination of education, training and experience.
Skills and Abilities
In-depth knowledge of the drug development processes.
Ability to apply advanced biostatistical methods in innovative trial designs through consultative interaction with regulators and customers.
Familiarity with master protocols, adaptive designs, and hybrid real-world evidence studies.
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
Strong client management skills.
Strong leadership skills.
Effective presentation skills.
Proficient in the use of Microsoft Office.
Strong written and verbal communication skills including good command of English.
Excellent organizational and problem-solving skills.
Effective time management skills and ability to manage competing priorities.
Expert ability to analyze metrics and information; ensuring activities and strategies are data driven.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Keywords: FDA, regulatory, Bayesian, adaptive, master protocol, real-world evidence, statistical science, mathematical decision science
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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.
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [email protected] to arrange for such an accommodation.