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Senior Clinical SAS Analyst
2 months ago
We are seeking a skilled professional to take on the role of Clinical SAS Programmer. This position involves significant responsibilities in the realm of statistical programming within the pharmaceutical and biotechnology sectors.
Key Responsibilities:
- Independently design and validate programs that produce SDTM and analysis datasets in accordance with ADaM specifications.
- Prepare and conduct quality checks on documentation for ADaM datasets, including Reviewer's Guide and analysis metadata reports.
- Develop and validate programs to generate tables and listings as outlined in the protocol or Statistical Analysis Plan (SAP).
- Execute quality control measures on final reports to ensure accuracy and compliance.
- Provide comprehensive QC and validation reports to stakeholders.
- Assist in the creation of technical programming specifications aligned with ADaM standards.
- Engage in effective communication with programming leads, statistical teams, data managers, and other collaborators.
- Deliver updates on project progress regarding programming activities.
Qualifications:
- Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related Life Sciences field.
- A minimum of 10 years of experience in statistical programming within the Pharmaceutical, Biotechnology, or Contract Research sectors.
- Proficient in SAS programming, with expertise in both Windows and UNIX environments, including SAS/Base, SAS Macros, and SAS/Stat.
- Familiarity with SAS Grid environments and experience using SAS Enterprise Guide and SAS Studio is advantageous.
- Experience across all clinical trial phases (I, II, III, and IV) is preferred.
- Solid understanding of clinical trial standards such as CDISC, SDTM, ADaM, MedDRA, and WHODRUG.
- Strong analytical and problem-solving abilities.
- Excellent organizational and time management skills.
- Outstanding communication skills, with the ability to convey technical concepts clearly.
- Proven ability to manage multiple tasks and deliver effective solutions in a dynamic environment with shifting priorities.