Sr. Statistical Science Director, Novel Trial Designs (Home or
Office-based) Durham, North Carolina, United States of America
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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
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
Represent IQVIA and its Clients at FDA and EMEA meetings
Perform statistical and mathematical modeling and decision
Market IQVIA strategic and innovative statistical science
expertise, that may include: (i) publishing papers; (ii) giving
presentations at conferences; (iii) and publicizing internally to
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
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 10 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
10 years of experience working on clinical trials with 8 years
of experience in a leadership capacity supporting clients and new
business or equivalent combination of education, training and
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
Familiarity with master protocols, adaptive designs, and hybrid
real-world evidence studies.
Knowledge and ability to apply GCP/ICH and applicable regulatory
Strong leadership 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
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
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 67,000+
employees around the world who apply their insight, curiosity and
intellectual courage every step of the way. Learn more at
IQVIA is an EEO Employer - Minorities/Females/Protected
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@example.com to arrange for such an
Posted 11 Days Ago
About Us At IQVIA, we have a vision. Where every healthcare
decision is based on evidence. Where data science and human science
come together to improve global health. Where new and creative
solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It
takes insight, curiosity, and intellectual courage to transform
healthcare. The 56,000+ employees of the IQVIA family of companies,
including Q2 Solutions, are reimagining a world without the
consequences of disease. We are brave minds bringing powerful ideas
to reality. At IQVIA, you can truly make an impact in an
environment where you’re supported to succeed.