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Assoc Director, Statistical Programming

United States - North Carolina - Raleigh, United States - California - Foster CityClinical Development & Clinical OperationsRegular

Job Description

Associate Director, Statistical Programming

(Macro Support)

Job Summary

Leads statistical programming tool development (e.g., SAS macros, automation solutions) supporting multiple studies and/or workstreams and ensuring delivery of high-quality, scalable tools aligned with Clinical Data Science and Statistical Programming standards. Contributes to departmental strategies, tools, and infrastructure that enable efficiency and consistency across Statistical Programming.

Key Responsibilities

Leadership & Delivery

  • Accountable for planning and delivery of tool development aligned with study and business timelines.

  • Influences design, development, qualification, and maintenance of SAS macros and related tools used across multiple studies or initiatives.

  • Acts as a project or functional lead for statistical programming tool initiatives.

  • Identifies cross-project synergies to improve efficiency, consistency, and reuse of tools and processes.

Technical & Functional Expertise

  • Maintains advanced knowledge of statistical programming good practices, data standards and norms.

  • Designs and develops tools in SAS Macro (required); familiarity with Linux scripting, R, or Python preferred.

  • Ensures tools comply with Gilead systems development procedures and regulatory requirements.

  • Drives adoption of standardized programming tools, templates, and methodologies following documented workflows.

  • Anticipates and resolves technical challenges, providing guidance to team members.

  • Provides primary and secondary tool development support as needed.

Strategy & Continuous Improvement

  • Contributes to development of departmental strategies, standards, and infrastructure for statistical programming tools.

  • Leads or contributes to initiatives that improve efficiency, automation, and scalability across programming workflows.

  • Evaluates and recommends new tools, processes, or technologies to enhance productivity and data flow.

Collaboration & Influence

  • Represents Clinical Data Engineering and Macro Support in cross-functional meetings.

  • Partners with stakeholders (e.g., GCDS, Study Statistical Programmers, Data Management) to define user-defined specifications, align priorities, and deliver solutions.

  • Builds cross-functional buy-in and influences decisions related to tools, standards, and timelines.

  • May interact with external vendors and ensures alignment with internal standards.

Communication & Decision-Making

  • Communicates effectively with stakeholders across multiple functions and organizational levels.

  • Resolves conflicts and escalates risks appropriately while maintaining project momentum.

Basic Qualifications

  • PhD with 5+ years

OR

  • MS with 8+ years,

OR

  • BS with 10+ years of relevant experience in statistical programming or related field.

Preferred Qualifications

  • MS with 8+ years,

OR

  • BS with 10+ years of relevant experience in statistical programming or related field.

  • Significant experience in life sciences, including clinical trials, analysis, and regulatory reporting.

  • Demonstrated experience leading projects and/or teams.

  • Knowledge of internal Gilead Analysis and Reporting macros is not required but desired.

Skills & Competencies

  • Advanced expertise in statistical programming and tool development (SAS Macro required).

  • Strong understanding of clinical trial design and reporting process, as well as regulatory requirements.

  • Strong problem-solving, negotiation, and decision-making skills.

  • Excellent verbal and written communication and interpersonal skills are required.