Senior Statistical Programmer (Clinical)
REMOTE, IL 00000 US
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.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.