USITLSP - Lead Statistical Programmer
4 days ago
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.
- 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.
- 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.
- 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.
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.
- Relevant experience in the pharmaceutical or medical device industry.
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