RWE - Biostatistician 2 - Canada
IQVIA
Kirkland, CA
4d ago

Job Description

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.

Responsibilities :

  • As a member of study teams that includes a Lead Statistician, responsible for the quality and timeliness of all statistical deliverables of the assigned studies.
  • Ensures efficient planning, execution and reporting of clinical studies.
  • In collaboration with the Lead Statistician, creates study design and analysis planning based on study outline.
  • Reviews protocols to ensure statistical integrity and optimal study designs.
  • Reviews and provides input into critical documents as Study Team Member, such as eCRFs and Data Validation Plans.
  • In collaboration with the Lead Statistician, helps develop statistical analysis plans (SAPs)
  • Develops tables, listings, and figure (TLF) specifications.
  • Performs statistical analyses for clinical studies in accordance with the protocol, statistical analysis plan, good statistical practice, and available regulatory guidelines.
  • Implements study analyses, including review of dataset specifications, providing programmers with efficacy analyses algorithms, programming or QC-
  • ing inferential statistical analyses and reviewing outputs and analysis results.

  • Interacts with Study Team programmers in the coordination of data summaries and analysis activities.
  • Leads and organizes review meetings, such as TLF review meetings, data review meetings and classification meetings.
  • In collaboration with the Lead Statistician, writes (executive) topline reports.
  • In collaboration with the Lead Statistician, contributes to clinical study reports and provides statistical interpretation of the results.
  • May represent the company on statistical matters at investigator meetings or meetings with key opinion leaders
  • Ensures quality and consistency of key data science deliverables across assigned studies within a project. Supports creation of, maintenance and adherence to indication specific standards with respect to key variables, definitions, statistical methods, data structures and presentation of results.
  • Required qualifications :

  • M.S or Ph.D. in Statistics or equivalent degree
  • Minimum of 3 years of experience in applying statistical methods in biomedical research, pharmaceutical or CRO industry experience required
  • Good knowledge of statistical methods for design of clinical studies and analysis of clinical data
  • Very good oral and written communication skills. Able to clearly communicate statistical issues and methods to both statisticians and non statisticians.
  • Ability to interact across different cultures, builds global relationships.
  • Accurate and keen eye for detail. Dedication to quality and reliability in all work tasks
  • Very good interpersonal skills to effectively work in cross-functional project teams
  • Good knowledge and skills in SAS required and knowledge of other statistical software strongly preferred
  • In depth familiarity with processes and procedures in data management and SAS programming
  • Good organizational, project and time management skills.
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