Sr. Statistical Science Director, Novel Trial Designs (Home or Office-based)
Company: IQVIA LLC
Posted on: September 16, 2020
Strong client management skills.. Effective presentation
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IQVIA3.6?. Sr. Statistical Science Director, Novel Trial Designs
(Home or Office-based). IQVIA™ is the leading human data science
company focused on helping healthcare clients find unparalleled
insights and better solutions for patients. Formed through the
merger of IMS Health and Quintiles, IQVIA offers a broad range of
solutions that harness the power of healthcare data, domain
expertise, transformative technology, and advanced analytics to
drive healthcare forward.. 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..
Responsibilities. 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.. Experience. Typically requires a
minimum of 10 years of prior relevant experience. Direct experience
working with regulators, especially the FDA, is preferred..
Knowledge. Requires exceptional domain and business knowledge to
drive results for the organization.. Applies extensive business and
industry expertise and provides organizational thought leadership..
Education. 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 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 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 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. #LI-GaleBurns. Join Us.
Making a positive impact on human health takes insight, curiosity,
and intellectual courage. It takes brave minds, pushing the
boundaries to transform healthcare. Regardless of your role, you
will have the opportunity to play an important part in helping our
clients drive healthcare forward and ultimately improve outcomes
for patients.. Forge a career with greater purpose, make an impact,
and never stop learning.. IQVIA is an EEO Employer -
Minorities/Females/Protected Veterans/Disabled. 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 firstname.lastname@example.org to arrange for such an
accommodation.. Apply Now!. Get alerts to jobs like this, to your
Keywords: IQVIA LLC, Durham , Sr. Statistical Science Director, Novel Trial Designs (Home or Office-based), Other , Durham, North Carolina
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