Job description
- Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s).
- Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets.
- Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements.
- Provides input in the design and development of case report forms and clinical databases.
- Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs.
- Programs quality checks for clinical study raw data and report the findings to Data Management.
- Provides input in the design and development of case report forms and clinical study databases.
- Reviews or author eCRF, SDTM and ADaM datasets specifications for datasets programming.
- Provides programming support for adhoc analysis.
- Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications).
- Manages timelines and schedules of specific phases of projects with internal personnel and external vendors.
- Acts as lead programmer for a study.
- Reviews or validates statistical deliverables of vendors for assigned project(s).
- MS in Statistics, Computer Science, or a related field with at least 3 years or BS in Statistics, Computer Science, or a related field with at least 5 years.
- Experience in providing statistical programming support to early and late phase clinical trials.
- Excellent skills in SAS programming and statistical reporting.
- Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
- Familiarity with FDA and ICH regulations and guidelines.
- Excellent problem-solving skills.
- Good written and verbal communication skills and organizational and documentation skills.
- Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.
- Ability to prioritize and multi-task effectively.
- Demonstrated positive attitude and the ability to work well with others.
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Frequently asked questions
Q: What skills or qualities help someone succeed as a SAS Clinical Programmer?
A: To succeed as a SAS Clinical Programmer, key technical skills include proficiency in SAS programming languages (e.g., SAS, SAS Macro, and SQL), experience with clinical data management systems, and knowledge of regulatory guidelines (e.g., ICH E3, CDISC). Soft skills such as strong analytical and problem-solving abilities, effective communication and collaboration, and attention to detail are also crucial for success in this role. These technical and soft skills enable Clinical Programmers to efficiently manage and analyze clinical data, ensuring high-quality deliverables and contributing to the success of clinical trials, ultimately supporting career growth and effectiveness in the role.
Q: What is the career path for a SAS Clinical Programmer?
A: A SAS Clinical Programmer's career path typically begins as a Clinical Programmer or SAS Programmer, where they develop and maintain clinical data management systems, and progress to roles such as Senior Clinical Programmer or Lead Programmer, overseeing complex projects and mentoring junior team members. Mid-level roles like Clinical Data Manager or Biostatistician also become opportunities for growth, where they apply programming skills to data analysis and interpretation. Ultimately, senior roles like Clinical Data Scientist or Director of Clinical Programming offer long-term career prospects, where they can leverage their expertise to drive strategic decision-making and innovation in the pharmaceutical or biotechnology industry.
