The Emmes Company - Senior SAS Programmer

Key Responsibilities :

- Design, develop, and validate SAS programs to support the analysis and reporting of clinical data across multiple phases of clinical trials.

- Program datasets in accordance with CDISC SDTM and ADaM standards, ensuring regulatory compliance.

- Create and maintain programs for data cleaning, data extraction, integration, and derivation of analysis-ready datasets.

- Generate statistical tables, listings, figures (TLFs), randomization schedules, and web-based reports as per the Statistical Analysis Plan (SAP) and table shells.

- Participate in the review and development of programming specifications, including dataset specifications, define.xml, annotated CRFs, and validation plans.

- Identify data issues, inconsistencies, and anomalies, and collaborate with Data Management and Biostatistics to resolve them.

- Support the creation and maintenance of documentation including Data Management Plans, Validation Plans, Statistical Analysis Plans, and other related project documentation.

- Conduct code reviews, QC checks, and contribute to validation and testing procedures to ensure accuracy and consistency.

- Interact with cross-functional teams and clients to discuss programming requirements, timelines, and deliverables.

- Ensure all programming activities comply with GCP, ICH guidelines, and other applicable regulatory standards.

- Contribute to process improvement initiatives and development of internal programming tools and macros.

- Perform all project and process-related activities as assigned, including project planning, timelines management, and communication documentation.

Candidate Requirements :

- Bachelor's or Master's Degree in Statistics, Mathematics, Engineering, Computer Science, Pharmacy, or a related discipline.

- Minimum 4 years of experience as a SAS programmer in the pharmaceutical industry or CRO environment.

- Proficiency in SAS/Base, SAS/Macro, SAS/SQL, and other related tools.

- Hands-on experience in developing datasets and outputs conforming to CDISC SDTM and ADaM standards.

- Strong understanding of clinical trial data structures, medical terminologies, and statistical analysis concepts.

- Experience in developing, documenting, and validating analysis datasets and programming code as per company and regulatory requirements.

- Knowledge of regulatory standards (FDA, ICH, GCP) and submission requirements for electronic datasets.

- Good problem-solving and analytical thinking skills to process complex clinical and scientific data.

- Ability to work both independently and in collaborative teams with cross-functional stakeholders.

- Excellent communication skills (verbal and written) and good time management with flexibility to adapt to shifting priorities