The Planet Group
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http://www.theplanetgroup.com
http://www.theplanetgroup.com
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Target Range: Market Rate
**salary will be commensurate with experience**
Essential Functions Include:
Qualified candidates must have:
Senior Statistical Programmer (Clinical)
Posted: 01/24/2023
2023-01-24
2023-02-25
Employment Type:
Direct Hire/Perm
Job Number: 520621-1
Country: United States
Is job remote?: Yes
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.