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IQVIA

Runs drug trials and sells health data to pharma

Biostatistics Director

Quantitative Biology & BiostatisticsUpdated on Nov 7
Full-timeDurham, NC, USA

About the Job

Requirements

  • A PhD or MSc degree in Statistics, Biostatistics, or a related field, along with 11 to 13+ years of experience within the life-science industry; a PhD is preferred, or equivalent experience.
  • Strong knowledge of complex statistical methods applicable to clinical trials.
  • Experience with clinical trial design is required; adaptive design is strongly preferred.
  • Experience interacting with regulatory bodies and working within pharmaceutical and contract research organization (CRO) compliance environments is required; FDA experience is preferred.
  • Working knowledge of SAS and CDISC Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).
  • Ability to manage multiple tasks and projects and to communicate and explain statistics.
  • Experience preparing budgets and proposals and participating in bid defenses.
  • Experience publishing papers, presenting talks at scientific conferences, and/or participating in webinars.

Responsibilities

  • Provide high-level statistical methodology guidance to internal and external clients as part of a statistical consultancy team.
  • Specialize in at least one area of statistical leadership and serve as a subject matter expert, leading the associated body of work while providing general consulting as needed.
  • Serve as a member of data monitoring committees, as a blinded or unblinded statistician.
  • Support trial and program design and associated analyses.
  • Work with medical, pharmacokinetic, and operational experts to write protocol synopses for clients; occasionally contribute to full protocols and provide consulting in advanced statistical analyses.
  • Provide thought leadership through publishing papers in peer-reviewed journals, referee and editor work, presenting at scientific conferences, and participating in by-invitation-only webinars.
  • Participate in bid defenses.
  • Travel to clients as needed.

Desired Qualifications

  • Adaptive design experience is strongly preferred.
  • FDA experience is preferred.
  • Experience teaching Statistics is preferred.

About the Company

IQVIA

Runs drug trials and sells health data to pharma

IQVIA runs clinical trials for drug, biotech and medical device companies and sells them the health data, software and analytics they use to develop and market treatments. Its research arm designs studies, recruits trial sites and patients, and manages trials through to regulatory filing. Its commercial arm sells market data, consulting and software that pharma sales and marketing teams use to plan product launches. Clients pay through multi-year service contracts and data and software subscriptions. IQVIA was formed in 2016 when clinical research firm Quintiles merged with health data company IMS Health, and it is based in Durham, North Carolina.

Company size
10,001+
Company stage
IPO
Headquarters
Durham, NC
Founded
1998

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