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Senior Statistical Programmer (Clinical)

REMOTE, IL 00000

Posted: 01/31/2023 Employment Type: Direct Hire/Perm Job Category: Data Sciences Job Number: 520621 Is job remote?: Yes Country: United States

Job Description


Target Range: Market Rate

**salary will be commensurate with experience**


Essential Functions Include:
  • Providing statistical programming and validation for clinical study reports, final/interim analyses, meetings, other types of analyses, and reports throughout the project.
  • Serves as a lead SAS/Statistical Programmer on programming projects.
  • Coordinating programming activities among the study programmers to achieve timely deliveries in the following areas: SDTM datasets, ADaM or analysis datasets, statistical tables, listings, and figures (TLFs), data reconciliation reports, and other internal and external reports.
  • Reviewing, updating, improving, and creating new standard program templates and macros to be used by programmers across the department to increase efficiency and consistency.
  • Reviewing and providing suggestions to department management for updates to SOPs and Work Instructions, and writing/updating specified documents as assigned.
  • Accessing and converting data to SAS datasets and other file types from the database management system and PC file formats (e.g., Microsoft Excel, text files).
  • Working with external vendors to develop and/or monitor the content and structure of SAS datasets and other files.
  • Overseeing programming activities by external vendors (e.g., CROs).
  • Working closely with statisticians and other statistical programmers to generate and validate TLF outputs; review data specifications to ensure accuracy and ensure the quality and soundness of statistical programming algorithm.
  • ·       Providing input in developing specifications of tabulation and analysis datasets, validation plans, and other related documents.
  • Reviewing data submission packages including define files and data reviewers guide documents.
  • Working independently to accomplish tasks and goals defined by supervisor as well as suggesting new ideas to improve the programming process.
  • Mentoring less-experienced statistical programmers.

Qualified candidates must have:
  • Minimum: Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related discipline, or a combination of other education with applicable professional experience.
  •  Minimum 5 years’ experience in SAS/statistical programming, preferably for clinical trials in a pharmaceutical/CRO environment.
  • Project leadership experience in a pharmaceutical/CRO programming environment preferred.
  • Experience using Base SAS, SAS/Macro, SAS/ACCESS, SAS/STAT, Microsoft Word, and Microsoft Excel.  Experience with SAS ODS Graphics preferred.
  • Experience following CDISC data standards (e.g., SDTM, ADaM) preferred.
  • Understanding of FDA, PMDA, and ICH guidelines preferred.
  • Good organization, time management, and attention to detail needed to work in a fast-paced environment under tight deadlines while maintaining focus on details and quality.
  • Applies good judgment and demonstrates initiative to resolve issues.
  • Strong written and interpersonal communication skills needed to work effectively in a team environment.
** CO/NYC candidates might not be considered**
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