SAS Programming Manager

Type: Permanent
Location: Fully remote

Responsibilities

• Aligning FSP assignments with Development priorities and ensuring FSP programming meets quality, compliance, timeline, and productivity expectations
• Ensuring FSP adherence to Policies, SOPs and other controlled documents as per Scope of Work
• Contributing to FSP training material development and revisions, and conducting the initial training to FSP staff
• Providing guidance to FSP Study Lead Programmers (SLP) on GSP processes, tools, and utilities
• Contributing to FSP performance metrics data collection and reporting

Key Project Responsibilities:

• Align with Statistician, Product Lead Programmer, and FSP Study Lead Programmer on project priority, timelines, deliverables, quality oversight plan, and data standards
• Conduct kickoff meeting with FSP staff for each outsourced project
• Collaborate with company's Statistician to develop the Project Delivery Plan for FSP deliverables and implement the plan
• Routinely review project documentations such as issue logs, deliverable status follow up with FSP SLP on concerns or questions
• Represent company in audits and determine responses to audit questions and findings
• Capture specific issues leading to rework or timeline delays during the execution of the project
• Advise FSP SLP on study-specific questions for specifications, documentation, and coding

Key Management Responsibilities:

• Monitor and report on the performance of the FSP operating model; make recommendations for refining the model
• Monitor and report on FSP performance, including metrics and adherence to service level agreements around quality, compliance, productivity, and timeliness of deliverables
• Contribute to FSP training material development and provide initial training to FSP  

Basic Qualifications:

• Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject
• Extensive statistical programming experience
• Thorough understanding of clinical trial processes from data collection to analysis reporting
• Ability to lead programmers in successful completion of all study programming activities and provide guidance on technical and process questions
• Experience working in a globally dispersed team on Phase 1-4 clinical trials
• Advanced SAS analysis and reporting skills including SAS Base, macro, and SQL
• Hands-on experience in specifying and implementing SDTM and ADaM data sets, and TFLs
• Ability to define and implement an effective standardization strategy for a product following the latest CDISC SDTM, ADaM and define standards