• Job Description

  Req#: R1360996

  PURPOSE:

  Provide statistical consulting and technical support as it relates to the design and statistical analysis of clinical studies. Determine analysis and data presentation specifications for SAS Programming staff. Perform analysis, interpret study results, and collaborate with medical and biostatistics staff to produce interim reports and final reports. May be responsible for more than one study.

  ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Collaborates with program staff on the implementation and analysis of statistical aspects of research protocols.
  • Assists Senior Statistician in providing statistical consultation for clinical programs, including but not limited to randomization, sample size assessments, efficacy evaluations, and data review.
  • Interfaces with clients as the project biostatistician.
  • Provides input to project timelines, and ensures that project timelines for biostatistics deliverables are met for both internal and external clients.
  • Ensures that project tasks are completed with acceptable quality for both internal and external clients.
  • Coordinates with SAS programming staff to ensure the accurate programming of SAS clinical data extracts and data displays.
  • Develops statistical analysis summary and analysis plans, including textual description of planned analysis and mock-ups of data displays.
  • Reviews and provides comments on statistical summaries.
  • Develops programming specifications to summarize the results of clinical trials, including analysis datasets and tables/listings/figures.
  • Performs statistical analyses, including hypothesis testing and modeling.
  • Provides tabular and written summaries of analyses and statistical methodology for Clinical Study Reports.
  • Interacts with Medical Writers to ensure appropriateness of data inferences.
  • Writes pertinent sections of a clinical study report.
  • Attends team meetings and represents departmental needs for assigned projects.

  KNOWLEDGE, SKILLS AND ABILITIES:

  • Ability to synthesize results in graphic, oral, and written reports.

  • Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.
  • Good working knowledge of CDISC SDTM and ADaM
  • Experience with statistical methods commonly used in the analysis of clinical trial data.
  • Experience with SAS Base and SAS Stat, as well as strong data step skills.
  • Experience with other statistical software packages, such as N-Query, S-Plus.
  • Ability to work creatively and independently to carry out assignments of a complex nature.
  • Ability to work effectively and cooperatively with other professional staff members.
  • Ability to communicate effectively, both verbally and in writing, with all levels of staff and with the public.

  MINIMUM RECRUITMENT STANDARDS:

  Degree requirements include one of the following:

  • Masters-level degree in Statistics, Biostatistics or related field with four years relevant work experience; total work experience to include one year in CRO industry or biotech; or
  • Doctorate-level degree in Statistics, Biostatistics or related field with two year relevant work experience in CRO industry or biotech.
  • Data handling and analysis experience.
  • Excellent interpersonal and organization skills.

  IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

• About the company

  IMS Health and Quintiles are now IQVIA. We are committed to providing solutions that enable healthcare companies to innovate with confidence, maximize opportunities and, ultimately, drive healthcare forward. We do this via breakthroughs in insights, t...

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