Statistical Programmer

Statistical Programmer Job Description Template

Our company is looking for a Statistical Programmer to join our team.

Responsibilities:

  • Develop/validate and review of SDTM and ADaM data specifications;
  • Works closely with other programmers to ensure the quality of all deliverables and project timelines are met;
  • Work collaboratively with study biostatistician by reviewing and providing inputs for study statistical analysis plan and TFL shells;
  • Provide statistical programming support to the clinical study team for all assigned clinical project;
  • Ensure that all departmental standard operating procedures that govern any aspect of their work are adhered to;
  • Prepare data submission packages including define.xml and data reviewers guide;
  • Create/validate CDISC compliant SDTM and ADaM datasets by following data specification;
  • Archive relevant documentation and deliverables;
  • Perform other duties that may be requested by management as assigned;
  • Review and provide comments on statistical analysis plan and data display documents;
  • Review and provide feedback on Master Plan for assigned project;
  • Review statistical analysis plan and data display documents as needed, to provide feedback on programming feasibility and efficiency;
  • Assume responsibility for project study budget and perform monthly time projections for each project;
  • Contribute to process improvement initiatives;
  • Review and provide input to project timelines and ensure that project timelines are met for both internal and external clients.

Requirements:

  • Oncology or/and regulatory submission experience preferred;
  • Proven knowledge of clinical trials, CDISC standards, regulatory guidance, GCP, and ICH Guidelines;
  • Good knowledge of SAS Base, SAS Graph and SAS Macro;
  • Bachelor s degree with 5+ years or Master s degree with 3+ years of work experience in pharmaceutical/biotech or related industry;
  • Must have good verbal and written communication skills;
  • Good verbal and written communication skills;
  • Advanced programming skills in data manipulation, statistical analysis, and reporting;
  • Ability to manage multiple assignments in a timely fashion;
  • Work well independently and in a team environment;
  • Experience managing and analyzing large databases;
  • BS in Economics, Statistics, or other related fields;
  • Stata and SQL experience;
  • Ability to interpret data and draw conclusions/make suggestions based on analysis;
  • US Citizen.