USITLSP - Lead Statistical Programmer

4 days ago


Denver, United States NavitsPartners Full time
Job Title: Lead Statistical Programmer

Reports to: Head of Statistical Programming

Job Purpose

Responsible for overseeing the timely, quality-driven, and cost-efficient execution of all statistical programming aspects for assigned studies or project-level activities. Acts as the primary liaison between statistical programming and other clinical trial team members.

Key Responsibilities
  • Lead statistical programming activities for studies, including requirements analysis, resource estimation, planning, tracking, and development.
  • Develop and review dataset specifications to ensure accuracy and compliance.
  • Coordinate and oversee the work of programming teams, facilitating kickoff meetings and defining roles, responsibilities, timelines, and standards.
  • Remove barriers to timely and high-quality deliverables and ensure programmers have the necessary resources.
  • Provide solutions to programming challenges and ensure their efficient implementation.
  • Maintain effective communication with clinical teams, reporting status, risks, and mitigation strategies.
  • Contribute to the development of standards, processes, and knowledge-sharing initiatives.
  • Ensure all deliverables meet audit and quality control standards and that statistical analysis outputs are accurate and reliable.
Key Performance Indicators
  • Timeliness and quality of statistical programming deliverables.
  • Effectiveness in leading and coordinating teams.
  • Strong communication and collaboration within clinical trial teams.
  • Compliance with internal and regulatory standards, as measured by audit outcomes.
  • Ability to work with minimal supervision while maintaining high-quality outcomes.
Impact on Organization
  • High-quality statistical programming deliverables that support timely product submissions, reducing potential project delays and financial risks.
  • Efficient programming leading to faster development and registration processes.
  • Maintaining the organization's positive reputation with regulatory authorities through high-quality submissions.
Competency Profile
  • Advanced SAS programming skills, including macro development.
  • Strong experience in resource planning, deliverable tracking, and team coordination.
  • Proficiency in developing dataset specifications.
  • Solid understanding of statistical concepts and regulatory guidelines (e.g., GCP, ICH) and industry standards such as CDISC.
  • Excellent communication and team collaboration skills.
Language Requirement

Fluency in English (reading, writing, speaking).

Education

Bachelor's, Master's, or equivalent degree in mathematics, statistics, computer science, health sciences, or a related field.

Minimum Requirements
  • At least 5 years of relevant programming experience.
  • Minimum 2 years of experience leading statistical programming activities.
Preferred Requirements
  • Relevant experience in the pharmaceutical or medical device industry.


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