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Senior Statistical Programmer

Main Responsibilities and Accountabilities

Work with clinical study teams to design data structures and specifications for ad hoc and study deliverables, including ADaM datasets, tables, figures, listings, and analysis submission content.
Collaborate with study teams to ensure clinical data is accurate, complete, and ready for regulatory submission, including SDTM, ADaM, tables, figures, listings, and define.xml.
Lead and oversee pooled and exploratory analysis activities in collaboration with Statistics Therapeutic Area leads, study statisticians, clinical programming teams, and teams managing legacy data.
Lead and oversee the internal specification and delivery of ISS and ISE datasets and related tables, figures, and listings when these are not supplied by a CRO.
Lead and oversee the design and implementation of complex SAS programs used to analyze and report clinical trial data in CDISC ADaM format.
Lead and oversee the development of global tools aimed at improving the efficiency and capacity of the Statistical Programming group.
Work closely with clinical study teams to plan and execute activities while ensuring project timelines are achieved and deliverables meet required quality standards.

Additional Tasks

Collaborate with CR&D staff on data analysis requests.
Conduct additional statistical analyses as required, including:
- Supporting responses to regulatory agencies.
- Generating integrated summaries of safety and efficacy.
- Supporting scientific publications and presentations.
- Supporting the planning and reporting of clinical trials through exploratory analysis of available data.

Position Qualifications and Experience Requirements

Education

Bachelor's degree in Computer Science, Mathematics, Statistics, or a related field, together with relevant professional experience.

Experience

At least 5 years of experience in clinical programming and/or statistical programming within a CRO or pharmaceutical environment.
In-depth understanding of clinical and/or statistical programming processes and applicable standards.
Extensive experience using SAS for statistical programming, including developing and using SAS macros.
Strong programming, analytical, and problem-solving abilities.
Hands-on experience with R programming is mandatory.
Advanced knowledge of CDISC standards, including CDASH, SDTM, and ADaM.
Demonstrated experience leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission-related activities, or equivalent experience.
Ability to work effectively both independently and as part of a team while managing personal timelines and meeting established objectives.
Experience working with cross-functional, multicultural, and international clinical trial teams.

Application

Statistical Programmer - FSP at IQVIA