Senior Statistical Programmer - FSP

IQVIA is an American multinational company specializing in health information technology and clinical research. It provides biopharmaceutical development and commercial outsourcing services, focusing on clinical trials and associated laboratory and analytical services.

The Senior Statistical Programmer will collaborate with study teams to design data structures and specifications for various ad hoc and study deliverables, including ADaM datasets, tables, figures, listings, and analysis submission content. They will ensure the quality and accuracy of clinical data for submission readiness, covering SDTM, ADaM, tables, figures, listings, and define.xml. The role involves leading and overseeing pooled and exploratory analyses, working closely with statistics leads and clinical programming teams, and managing the in-house specification and delivery of ISS and ISE datasets and outputs when not provided by a CRO. A key aspect is designing and implementing complex SAS programs for analyzing and reporting clinical trial data in CDISC ADaM format, as well as developing global tools to enhance the efficiency of the Statistical Programming group. The programmer will also work closely with clinical study teams to plan and execute activities, ensuring project timelines are met with high-quality deliverables. Additional tasks include collaborating with CR&D staff on data analysis requests and performing further statistical analyses to support regulatory agency responses, generate integrated summaries of safety and efficacy, support publications and presentations, and aid in planning and reporting clinical trials through exploratory data analyses.

1. Collaborate with study teams to design data structures and specifications for ad hoc and study deliverables, including ADaM datasets, tables, figures, listings, and analysis submission content.
2. Ensure the quality and accuracy of clinical data for submission readiness, covering SDTM, ADaM, tables, figures, listings, and define.xml.
3. Lead and oversee pooled and exploratory analyses, working with Statistics TA leads, study statisticians, and clinical programming teams.
4. Lead and oversee the in-house specification and delivery of ISS and ISE datasets and associated outputs when not provided by a CRO.
5. Lead and oversee the design and implementation of complex SAS programs for analyzing and reporting clinical trial data in CDISC ADaM format.
6. Lead and oversee the development of global tools to increase the efficiency and capacity of the Statistical Programming group.
7. Work closely with clinical study teams to plan and execute activities, ensuring project timelines are met with high-quality deliverables.
8. Collaborate with CR&D staff on data analysis requests.
9. Perform additional statistical analyses to support regulatory responses, generate integrated summaries of safety and efficacy, support publications and presentations, and aid in clinical trial planning and reporting through exploratory analyses.

1. Hold a Bachelor of Science degree in Computer Science, Mathematics, Statistics, or a related field.
2. Possess at least 5 years of experience in clinical programming and/or statistical programming within a CRO or pharmaceutical environment.
3. Demonstrate an in-depth understanding of clinical programming and/or statistical programming processes and standards.
4. Have extensive experience with statistical programming using SAS software, including the development and use of SAS Macros, along with strong programming and problem-solving skills.
5. Mandatory experience in R Programming (hands-on experience required).
6. Possess advanced knowledge of CDISC standards (CDASH, SDTM, ADaM).
7. Proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities.
8. Ability to work effectively both independently and in a team setting, managing timelines to meet set goals.
9. Experience working in cross-functional, multicultural, and international clinical trial teams.