Overview
Senior Programmer Analyst II performing advanced statistical and clinical programming for clinical research projects, working independently as Lead Programmer or Study Lead on complex clinical studies.
What you'll do
- Act as the Lead Programmer or Study Lead on complex clinical studies, working directly with project leaders and client representatives to manage programming activities, timelines, resources, and deliverables.
- Independently manage end-to-end clinical SAS programming activities, including SDTM dataset creation, ADaM dataset development, and generation of Tables, Listings, and Figures (TLFs).
- Develop, execute, maintain, and validate SAS programs to support clinical trial data analysis and reporting.
- Ensure compliance with CDISC standards, including SDTM and ADaM, and applicable clinical programming guidelines.
- Lead programming activities across clinical studies, ensuring timely delivery of high-quality datasets, analysis outputs, and supporting documentation.
- Collaborate with Biostatistics, Clinical Data Management, and other cross-functional teams to meet study objectives.
- Perform quality control and validation of statistical programming deliverables, ensuring accuracy, consistency, and regulatory compliance.
- Manage multiple programming assignments, prioritize deliverables, and ensure adherence to project timelines and departmental SOPs.
- Provide technical guidance, training, and mentorship to junior programmers.
- Participate in client meetings, project discussions, and programming reviews as the primary programming representative.
- Contribute to process improvements, programming standards, training materials, and departmental working practice documents.
- Support resource planning, project forecasting, and bidding activities when required.
What you'll need
- Master's degree in computer science, Statistics, Biostatistics, Mathematics, or a related field, with relevant clinical programming experience, OR Bachelor's degree in computer science, Statistics, Biostatistics, Mathematics, or a related field, or an equivalent relevant academic/vocational qualification.
- Minimum 7 years of end-to-end clinical SAS programming experience, including SDTM, ADaM, and TLF development, with proven experience independently leading clinical studies as a Study Lead Programmer.
- Strong hands-on experience in SAS programming, including Base SAS, SAS Macros, PROC SQL, and clinical reporting.
- Demonstrated experience independently managing programming deliverables across clinical studies.
- Experience working within the pharmaceutical, biotechnology, or CRO industry.
- Advanced proficiency in SAS programming, including Base SAS, SAS Macros, and PROC SQL.
- Strong knowledge of CDISC standards, including SDTM and ADaM.
- Extensive experience developing and validating Tables, Listings, and Figures (TLFs).
- Proven Study Lead or Lead Programmer experience managing complex clinical studies independently.
- Strong understanding of clinical trial processes, statistical programming, and regulatory requirements.
- Excellent analytical, problem-solving, and troubleshooting skills.
- Strong attention to detail and commitment to data accuracy and quality.
- Ability to independently manage multiple studies, assignments, and challenging timelines.
- Strong communication and stakeholder management skills, including the ability to interact effectively with clients and cross-functional teams.
- Demonstrated leadership skills with experience mentoring and guiding junior programmers.
- Strong understanding of relational databases and complex clinical data structures.
- Ability to identify process improvements and contribute to programming efficiency.
Details
- Work schedule: Second Shift (Afternoons).
- Work is performed in an office environment with exposure to electrical office equipment.
- Occasional travel to site locations, including domestic and international travel, may be required.
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