Summary of Position
The Principal SAS Programmer is responsible for providing timely support to clinical study teams on all programming matters (from simple to complex) related to processing data from clinical studies. Assumes the role of Lead programmer on studies. Create, document, and validate corresponding related SAS programs, datasets, and outputs needed for the analysis, interpretation, and monitoring of MacroGenics clinical trials. Respond to both planned and ad-hoc data requests from Data Management, Clinical Operations, Product Safety, Medical Research, and Biostatistics. Participates actively in project teams. Works mostly independently but occasionally seeks the guidance of a more experienced programmer. Interact with external parties as a representative of Clinical Programming.
Responsibilities and Job Duties
- Act as Lead Programmer on studies: responsible for the generation of study deliverables and being Clinical Programming point of contact for other functions.
- Retrieves clinical data and metadata from Clinical Data Management Systems (CDMS) and creates SAS datasets from other systems (IWRs, Labs, etc.)
- Develops, validates, and documents programs/generic SAS Macros/systems (from simple to complex) for creating output for:
- Edit checks and reports specified in the Data Validation Plan
- TLFs needed for analyses and reporting, including CSRs, DSURs, IBs, and dose escalations.
- Ad-hoc requests in support of data collection/cleaning/data presentations/analyses
- CDISC output, including SDTM, Adam datasets, specifications and define.xml documentations
- Reviews and provides feedback on CRF design, Database design, and the output SAS datasets from the database to ensure that the clinical database and the data it will contain are conducive to efficient and error-free SAS programming
- Reviews and provides programming input to SAP, SPP (statistical programming plan) and ADaM specification creation
- Interacts with CROs, vendors, and consultants involved in MacroGenics studies and ensures quality services are provided:
- Review data transfer specifications if any
- Communicate with CRO/Vendor/Consultant in the area of SAS Programming and data files to ensure that received external deliverables meet MG needs
- Participates in standardization efforts
- Provides effective leadership among programmers. Leads, finds solutions, or makes decisions when facing challenge programming related tasks or working with a team
- Assess impact of new SAS versions on existing processes and systems. Actively explores, contributes or solicits ideas that would lead to the creation of better programming codes or efficient programming process.
- Keeps abreast of biopharmaceutical trends and best practices in the use of SAS. Discuss technical/software concepts with the group. Mentors less experienced SAS programmers, and provides technical assistance to others in the MacroGenics SAS user community
- Develops and maintains effective and efficient communication lines both within the CP group and with other groups, and demonstrates a positive leadership style
- Follows, writes, and monitors MacroGenics' programming and quality standards, SOPs and WPs
- Represents CP at project team meetings and interacts with cross-functional team members independently
- Represents Clinical Programming with business partners for study specific matters
- Presents to internal audiences on study-specific issues and processes. Attends and may present MacroGenics SAS programming know-how at external conferences and seminars.
- Works independently on SAS matters, solves problems proactively, and determines when and how to escalate issues
- Keeps manager informed of progress and any issues that may impact process compliance, data integrity, reporting accuracy, long term efficiency, timelines, or quality
- Performs other functions as necessary or as assigned
Education & Other Credentials
Bachelor’s Degree in a scientific discipline, Mathematics, or Computer Science.
- 10 years of SAS programming experience
- 8 years of clinical trials experience
Knowledge, Skills and Abilities
- SAS Skills:
- Expert: SAS Base, MACROlanguage, ODS
- Advanced: SAS/STAT, SAS/Graph
- Demonstrated experience performing a leadership role in project teams.
- Demonstrated ability to plan and support multiple complex assignments with challenging timelines.
- Very good verbal and written communication skills
- Demonstrated experience with oncology clinical trials and CDISC data models