IQVIA

Senior Biostatistician

IQVIA

full-time

Posted on:

Location Type: Office

Location: Hyderabad • 🇮🇳 India

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Develop statistical methods sections of protocols and review case report forms (CRFs).
  • Prepare analysis plans and write specifications for analysis files, tables, and figures.
  • Communicate with clients regarding study protocol or statistical analysis issues as they arise.
  • Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results.
  • Interpret analyses and write statistical sections of study reports.
  • Accountable for controlling costs and maximizing revenue recognition.
  • Provide training, guidance and mentorship to lower level and new staff.
  • Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken.
  • Checks programming logs for cleanliness and correct processing of data.
  • Inputs into Data Issues log and follows issues to appropriate resolution.
  • Build and maintain effective customer relationships, driving statistical discussions, providing support and/or guidance for statistical activities.
  • Actively participates in internal project team meetings, provides timely progress updates.
  • Shares accountability (with resource managers) for the financial success of assigned studies.
  • Responsible for sharing budget expectations with the team.
  • Helps train staff regarding operational items. Mentors junior staff. Supports colleagues and provides motivation as needed.

Requirements

  • Bachelor's Degree Biostatistics or related field and 7 - 10 years relevant experience Req
  • Master's Degree Biostatistics or related field and 8-10 years relevant experience Req
  • Ph.D. Biostatistics or related field and 1 year relevant experience Req
  • Typically requires 3-5 years of prior relevant experience, or equivalent combination of education, training and experience.
  • Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.
  • Excellent written and oral communication skills including grammatical/technical writing skills.
  • Excellent attention and accuracy with details.
  • In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Familiarity with moderately complex statistical methods that apply to applicable clinical trials.
  • Strong individual initiative.
  • Strong organizing skills.
  • Strong working knowledge of SAS computing package.
  • Familiarity with other relevant statistical computing packages such as nQuery.
  • Strong commitment to quality.
  • Ability to effectively manage multiple tasks and projects.
  • Ability to lead and co-ordinate small teams.
  • Ability to solve moderately complex problems.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Benefits
  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
statistical methodsdata analysisstatistical analysisprogramming logsdata validationclinical researchGood Clinical Practice (GCP)International Conference on Harmonization (ICH)SASnQuery
Soft skills
communication skillsattention to detailorganizational skillsleadershipmentorshipproblem-solvinginitiativeteam coordinationrelationship buildingtraining