Description :

Experience : 711 Years

Industry : Clinical Research / Pharmaceuticals / CRO

Focus : SDTM/ADaM Standardization, CDISC Compliance, & Advanced SAS Architecture

Role Summary :

We are seeking a high-caliber Senior Statistical Programmer to lead the end-to-end development and validation of CDISC-compliant datasets.

This role is designed for a technical expert who possesses deep-tier mastery of SDTM and ADaM standards across various Therapeutic Areas (TAs) and clinical trial phases.

Beyond dataset generation, you will be the primary architect for Define.xml creation and Pinnacle 21 (P21) compliance orchestration.

As a subject matter expert in Base and Advanced SAS, you will drive engineering excellence by developing complex, generalized macros and GTL-based visualizations that scale across multiple global studies.

You will serve as a technical mentor, supervising developers to build high-efficiency clinical programming frameworks while ensuring strict adherence to evolving CDISC guidelines and Therapeutic Area User Guides (TAUGs).

Responsibilities :

- CDISC Dataset Orchestration: Lead the hands-on generation and validation of SDTM and ADaM datasets, ensuring seamless transformation from raw clinical data to analysis-ready formats.

- Compliance & Metadata Governance: Execute comprehensive compliance checks using Pinnacle 21 and oversee the creation of Define.xml, Reviewer's Guides (nSDRG/ADRG), and metadata repositories.

- Advanced Macro Architecture: Design and develop complex, reusable SAS Macros and generalized programs to automate repetitive data mapping and analysis tasks across multiple Therapeutic Areas.

- Therapeutic Area Expertise: Implement nuanced SDTM/ADaM concepts by leveraging a thorough understanding of TAUGs and cross-phase clinical trial requirements (Phase IIV).

- Technical Mentorship: Supervise and mentor junior developers in building generic standard macros, high-quality listings, and responding to business-critical ad-hoc requests.

- Complex Data Visualization: Utilize SAS GTL (Graph Template Language) and advanced procedures to develop sophisticated visual representations of clinical safety and efficacy data.

- Process Optimization: Review and optimize existing SAS code and macros to improve execution speed, maintainability, and resource utilization.

- SQL & Data Manipulation: Apply expert-level SAS SQL (PROC SQL) and advanced functions to handle complex data joins, merging, and large-scale data cleansing operations.

- Regulatory Knowledge Integration: Maintain an in-depth understanding of both current and legacy CDISC versions to support legacy data conversions and FDA/EMA submission requirements.

- Quality Control Oversight: Lead the peer-review process for clinical programs, ensuring zero-defect delivery of submission-ready data packages.

Technical Requirements :

- Core Programming: 7+ years of expert-level experience in Base and Advanced SAS programming within a clinical environment.

- CDISC Standards: Mastery of SDTM (v1.4+) and ADaM (v2.1+) models, including familiarity with ADAM-IG and SDTM-IG.

- Automation: Proven track record in developing global SAS Macro libraries and generalized clinical frameworks.

- Compliance Tooling: Hands-on proficiency with Pinnacle 21 Community/Enterprise for data validation and issue resolution.

- Database & Logic: High proficiency in SAS SQL, custom functions, and complex data step processing.

- Visualization: Strong experience in SAS GTL for generating complex clinical graphs and figures.

Preferred Skills :

- Cross-TA Experience: Diverse experience across Oncology, Cardiology, Immunology, or Rare Disease TAUGs.

- Submission Experience: Prior involvement in successful NDA/BLA/MAA regulatory submissions.

- Analytical Thinking: Ability to deconstruct complex clinical protocols into efficient programming specifications.

- Leadership Qualities: Strong communication skills to manage stakeholder expectations and lead remote developer squads.

- Knowledge of Open Source: (Bonus) Awareness of R-SESS or R-based clinical programming for future-state clinical reporting.