Responsibilities:

• Providing statistical programming and validation for clinical study reports, final/interim analyses, meetings, other types of analyses, and reports throughout the project.
• 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.

Requirements:

• 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.