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Key Responsibilities and Required Skills for an EG Statistical Programmer

💰 $95,000 - $140,000

BiostatisticsPharmaceuticalData ScienceClinical ResearchProgramming

🎯 Role Definition

The EG (Enterprise Guide) Statistical Programmer is a critical member of the clinical study team, responsible for the hands-on development and validation of SAS programs to support the analysis and reporting of clinical trial data. This role serves as a technical expert, ensuring that analysis datasets, tables, figures, and listings (TFLs) are generated with the highest accuracy and quality, adhering strictly to statistical analysis plans (SAPs) and regulatory standards like CDISC. You will collaborate closely with biostatisticians, data managers, and clinical scientists to ensure data is structured, analyzed, and presented in a clear, compliant, and meaningful way, directly contributing to the success of regulatory submissions and the advancement of new therapies.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Statistical Programmer I / Associate Statistical Programmer
  • Data Analyst (with SAS experience)
  • Junior Biostatistician

Advancement To:

  • Senior Statistical Programmer
  • Principal Statistical Programmer
  • Manager, Statistical Programming

Lateral Moves:

  • Biostatistician
  • Clinical Data Manager

Core Responsibilities

Primary Functions

  • Develop, test, and validate complex SAS programs using SAS Enterprise Guide to create and map clinical data to CDISC-compliant analysis datasets (SDTM and ADaM).
  • Generate and perform rigorous quality control on tables, figures, and listings (TFLs) according to detailed specifications outlined in the statistical analysis plan (SAP) and mock shells.
  • Author, review, and maintain comprehensive programming documentation, including dataset specifications, validation plans, and program annotation to ensure a clear audit trail.
  • Perform meticulous peer review of SAS programs and outputs generated by other programmers to guarantee accuracy, efficiency, and adherence to internal and industry standards.
  • Collaborate effectively with biostatisticians to interpret statistical analysis plans and provide programming expertise for the development of analysis dataset specifications.
  • Ensure all programming activities and deliverables are fully compliant with Good Clinical Practices (GCP), ICH guidelines, and applicable regulatory requirements.
  • Provide direct programming support for the preparation of clinical study reports (CSRs), integrated summaries of safety (ISS), and integrated summaries of efficacy (ISE).
  • Design, develop, and maintain a library of standardized, reusable SAS macros and utilities to enhance programming efficiency and promote consistency across multiple studies.
  • Actively participate in the review of case report forms (eCRF), data management plans, and statistical analysis plans to provide critical programming input from a technical perspective.
  • Troubleshoot and debug complex SAS code, systematically identifying and resolving data discrepancies, programming logic errors, and other technical issues.
  • Prepare and assemble electronic submission-ready data packages for regulatory agencies (e.g., FDA, EMA), including datasets, programs, and define.xml files.
  • Manage programming timelines and deliverables for assigned projects, proactively communicating project status, potential risks, and resource needs to the project team.
  • Assist in the development and refinement of departmental Standard Operating Procedures (SOPs), work instructions, and best practices for statistical programming.
  • Perform ad-hoc, exploratory analyses and generate custom reports to support publications, presentations, and responses to queries from regulatory authorities.
  • Ensure full traceability between requirements, specifications, code, and final outputs to maintain data integrity and support regulatory inspection readiness.
  • Provide technical mentorship and guidance to junior programmers, fostering a culture of knowledge-sharing and continuous improvement within the team.
  • Lead all statistical programming activities for assigned clinical studies, serving as the primary programming point of contact for the cross-functional study team.
  • Validate the functionality and output of third-party or CRO-developed SAS programs, ensuring they meet project specifications and quality standards.
  • Contribute to the creation and validation of define.xml or define.pdf files as a key component of the electronic submission package for regulatory review.
  • Evaluate and recommend new programming techniques, software tools, and innovative technologies to increase the efficiency and capability of the programming group.
  • Liaise with Clinical Data Management to understand the source data structure and resolve data quality issues identified during the programming process.

Secondary Functions

  • Support ad-hoc data requests and exploratory data analysis to answer novel questions from clinical and research teams.
  • Contribute to the organization's data strategy and process improvement initiatives.
  • Collaborate with business units to translate data needs into engineering requirements.
  • Participate in sprint planning and agile ceremonies within the data engineering team.
  • Assist in user acceptance testing (UAT) for new clinical data systems or analytical tools.

Required Skills & Competencies

Hard Skills (Technical)

  • Expert-level proficiency in SAS Programming, including Base SAS, SAS/STAT, SAS/GRAPH, and the SAS Macro Language.
  • Extensive hands-on experience using SAS Enterprise Guide (EG) for project management, code development, and execution.
  • Deep, practical knowledge of CDISC standards, with proven experience in developing and validating SDTM and ADaM datasets.
  • Demonstrated ability to generate and validate complex Tables, Figures, and Listings (TFLs) for clinical study reports.
  • Strong understanding of the clinical trial lifecycle, from study start-up to regulatory submission and post-marketing activities.
  • Proficiency working in Windows and/or UNIX/Linux environments.
  • Experience with regulatory submission processes and the creation of submission components like define.xml.
  • Familiarity with other statistical programming languages, such as R or Python, is a significant advantage.
  • Understanding of relational database principles and experience with SQL.

Soft Skills

  • Exceptional analytical and problem-solving abilities with a meticulous eye for detail.
  • Superior written and verbal communication skills, with the ability to articulate complex technical concepts to non-technical audiences.
  • Proven ability to manage multiple projects, prioritize tasks, and meet deadlines in a fast-paced environment.
  • Highly organized and capable of working both independently and as an integral member of a collaborative team.
  • A proactive and adaptable mindset, with a strong commitment to quality and continuous learning.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's Degree

Preferred Education:

  • Master's Degree

Relevant Fields of Study:

  • Statistics or Biostatistics
  • Computer Science or Data Science
  • Mathematics or Public Health

Experience Requirements

Typical Experience Range: 3-7 years of direct statistical programming experience, ideally within the pharmaceutical, biotechnology, or CRO industry.

Preferred: Demonstrable experience supporting successful regulatory submissions (e.g., NDA, BLA, MAA) and a track record of leading programming activities for multiple clinical studies are highly desirable.

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