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Sr. Statistical Programmer - United States  

Intercept (company)


Posted on : 21 March 2017

Project Description

To perform this job successfully an individual must be able to perform each essential function satisfactorily.
  •  Generate randomization schedules.
  • Provide sample size calculations.
  • Provide input into development of case report forms (CRFs).
  •  Author statistical analysis plans, including development of table and listing shells.
  •  Review statistical analysis plans written by CRO Bio-statisticians.
  • Generate/Validate analysis data-sets, tables, figures, and listings to support the analysis of clinical trials data using SAS.
  •  Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
  • Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
  • Provide statistical analysis and reports to Data Monitoring Committees (DMCs).
  •  Review output across programs to ensure consistency.
  • Prepare statistical sections of clinical study reports.
  •  Other duties as assigned.

  • Master’s degree in Statistics and a minimum of 5 years of relevant industry experience.
  • Knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines. 
  •  Experience with SAS.
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines. 
  • Excellent communication and interpersonal skills to effectively interface with others.

  • Strong verbal and written communication skills are essential.
  • Excellent organization and multi-tasking skills. 
  • Exceptional interpersonal skills and problem solving capabilities. 
  • Proven meeting planning skills. 
  •  Ability to work effectively across a matrix organization. 
  • Ability to work independently and prioritize with minimal daily instruction. 
  •  Ability to think strategically in order to improve current processes.