Principal Statistical Programmer.

Position Overview

As a Principal Statistical Programmer, you will serve as a senior technical expert within the individual contributor career track. You will independently develop, validate, document, and deliver high-quality SAS programming deliverables supporting the analysis and reporting of clinical trial results. The role will be accountable for the accuracy, quality, traceability, and reproducibility of its code and outputs. You will provide technical leadership on complex programming matters and serve as a technical resource to other programmers. This role will support the submission-readiness of study data packages by applying CDISC standards, applicable regulatory guidance, and internal standards. Working closely with Programming leadership, the role will contribute technical expertise to the continuous improvement of statistical programming standards, processes, tools, and infrastructure. This role may also collaborate cross-functionally with Biostatistics, Data Management, Clinical Development, and other functions. 

Responsibilities

• Develop and/or view programming specifications based on the Statistical Analysis Plan and oversee the creation, validation, and delivery of CDISC-compliant SDTM and ADaM datasets, TLFs, Define.xml, and reviewer guides. 
• Provide hands-on SAS programming support for key analyses, data exploration, ad hoc requests, and internal or regulatory deliverables, as needed.  
• Adhere to study programming timelines and evaluate dependencies, proactively identify risks, and ensure alignment with cross-functional study plans and key milestones. 
• Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Safety teams to review requirements, refine specifications, and resolve data or programming issues.  
• Review Data Management Plans, case report forms, data transfer specifications, external/vendor data specifications, and validation-related documentation to ensure data quality and downstream programming readiness.  
• Validate CRO-generated SDTM/ADaM datasets, TLFs, and submission components using industry-standard tools such as Pinnacle 21 to access CDISC compliance and support resolution of identified issues.  
• Lead technical initiatives to develop and maintain SAS macros, utilities, and programming standards, and reusable tools to improve efficiency, consistency, and scalability across studies. 
• Ensure adherence to CDISC standards, regulatory expectations, departmental SOPs, and best practices for statistical programming and data traceability.  
• Contribute to departmental initiatives, process improvements, and cross-functional projects beyond assigned study responsibilities.  
• May be required to lead statistical programming activities for assigned clinical studies working closely with Programming leadership.  

Qualifications

• A master’s degree (or higher) in Statistics, Computer Science or other closely related field to programming with minimum 4+ years of relevant pharmaceutical/biotech industry experience. 
• Requires solid knowledge of statistical programming principles, clinical trial process, and regulatory requirements. 
• Prior NDA submission and regulatory agency interaction experience highly desirable.  
• Prior Oncology/Hematology experience highly desirable.  

Knowledge and Skills

• Dynamic self-starter; agile learner; strategic and creative thinker. 
• Demonstrated strong problem solving and risk-mitigation skills.  
• Excellent verbal/written and interpersonal skills required to communicate and collaborate effectively with cross-functional teams (clinical operations, Scientists, Medical Monitors and Statisticians) in face-to-face conversation, by telephone, and by email. 
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.  
• Strong well-rounded technical skills (SAS, EDC systems, MS Word, Excel, PowerPoint, API based data extracts, ETL principles) and knowledge of industry standards (CDISC, SDTM, CDASH, ADaM).