Senior Statistical Programmer

Senior Statistical Programmer (FSP - Permanent Homebased) Join to apply for the Senior Statistical Programmer (FSP - Permanent Homebased) role at IQVIA. Why IQVIA This role will be dedicated to one of IQVIA’s largest clients through a Functional Service Provider (FSP) type partnership. You will benefit from working for a leading global CRO while operating within a sponsor environment and using sponsor systems. Sponsor clients include world-class pharmaceutical and biotech companies, offering a unique opportunity to work on a team where your role is challenging and rewarding, alongside colleagues passionate about influencing the future of medicine and advancing therapies. With IQVIA\'s FSP business unit, you become a core part of a dynamic team dedicated to reshaping the future of healthcare. Additional Benefits Home-based remote work opportunities Great work/life balance Collaborate on projects and innovations with industry leaders in the Pharma and CRO sectors Cohesive team environment fostering a collaborative approach to study work Variety of therapeutic areas, indications and study phases Job stability; long-term engagements and development opportunities Career advancement opportunities Job Description The Senior Statistical Programmer will be responsible for reviewing datasets in submission-ready standard format (ADaM), as well as tables, figures, listings and submission packages. This role provides expertise in the design, development and quality control processes for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses. Main Responsibilities And Accountabilities 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. Ensure the quality and accuracy of clinical data to meet submission readiness requirements (e.g., SDTM, ADaM, tables, figures, listings, define.xml). Lead and oversee requested efforts for pooled and exploratory analyses in partnership with the Statistics TA lead, study statisticians, clinical programming team, and legacy data teams. Lead and oversee the in-house specification and delivery of ISS and ISE datasets and associated output when not provided by CRO. Design and implement complex SAS programs for applications to analyze and report complex clinical trial data in CDISC ADaM format. Develop global tools to increase the efficiency and capacity of the Statistical Programming group. Collaborate with clinical study teams to plan and execute activities to ensure project timelines and high-quality deliverables. Additional Tasks Collaborates with CR&D staff regarding data analysis requests. Perform additional statistical analyses including but not limited to regulatory responses, integrated summaries of safety and efficacy, and support for publications and presentations. Support planning and reporting of clinical trials via exploratory analyses of available data. Position Qualifications And Experience Requirements Education BSc in Computer Science, Mathematics, Statistics or related area with relevant experience Experience At least 5+ years of experience in clinical programming and/or statistical programming within the CRO/pharmaceutical environment using SAS Software. In-depth understanding of clinical programming and/or statistical programming processes and standards. In-depth understanding of regulatory requirements relevant to statistical programming (e.g., GCP, ICH). Extensive experience with statistical programming using SAS, including development and use of SAS Macros. Strong programming and problem-solving skills. Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM). Proven experience leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities (or equivalent). Proven ability to work independently or in a team setting and manage timelines to meet goals. Experience working in cross-functional, multicultural and international clinical trial teams. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We connect people and data to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com Seniority level Mid-Senior level Employment type Full-time Job function Research, Analyst, and Information Technology Industries Hospitals and Health Care Referrals increase your chances of interviewing at IQVIA. #J-18808-Ljbffr