Senior Statistical Programmer
Remote · పూర్తి సమయం
దరఖాస్తు చేసుకునే వారిలో మొదటి వ్యక్తిగా ఉండండి
- అనుభవం
- 5+ yrs
- జీతం
- —
- ఖాళీలు
- 1
- పోస్ట్ చేయబడింది
- 1 రోజు క్రితం
ఉద్యోగ వివరణ
About the Role
IQVIA is seeking a Senior Statistical Programmer to join their Clinical FSP, sponsor-dedicated team. This role is homebased in Kenya and is fully remote, with no travel required. The primary focus will be on reviewing datasets, tables, figures, listings, and submission packages to ensure they meet submission-ready standards (ADaM). You will leverage your expertise in designing, developing, and quality controlling SAS programs for clinical data analysis, extraction, transformation, and submission.
Why Join IQVIA?
- Engage with industry pioneers on cutting-edge clinical innovation projects.
- Gain broad experience across diverse therapeutic areas, indications, and clinical trial phases.
- Benefit from career growth opportunities, including AI-powered advancement via the internal talent marketplace, Career Connections.
- Access mentorship through Employee Resource Groups.
- Enjoy flexible working arrangements to support work-life balance and professional achievement.
- Become part of a company recognized as a 2026 Fortune® World’s Most Admired Companies™ nominee for the fifth consecutive year.
Responsibilities
- Collaborate with study teams to define data structures and specifications for deliverables such as ADaM datasets, tables, figures, listings, and analysis submission content.
- Ensure the quality and accuracy of clinical data for submission readiness, adhering to regulatory standards like SDTM, ADaM, tables, figures, listings, and define.xml.
- Lead and oversee efforts for pooled and exploratory analyses, working closely with Statistics TA leads, study statisticians, and the clinical programming team, including the integration of legacy data.
- Lead and oversee the creation of Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) datasets and associated outputs when not provided by a CRO.
- Lead and oversee the design and implementation of sophisticated SAS programs for analyzing and reporting complex clinical trial data in CDISC ADaM format.
- Lead and oversee the development of global tools to enhance the efficiency and capacity of the Statistical Programming group.
- Work closely with clinical study teams to plan and execute activities, ensuring project timelines are met with high-quality deliverables.
- Collaborate with CR&D staff on data analysis requests.
- Perform additional statistical analyses, including supporting regulatory agency responses, generating integrated summaries of safety and efficacy, supporting publications and presentations, and aiding in the planning and reporting of clinical trials through exploratory analyses.
Requirements
- Possess a BSc in Computer Science, Mathematics, Statistics, or a related field, complemented by relevant experience.
- Accumulate a minimum of 5 years of experience in clinical programming and/or statistical programming within the CRO or pharmaceutical sector, utilizing SAS Software.
- Demonstrate an in-depth understanding of clinical and statistical programming processes and standards.
- Show extensive experience with statistical programming in SAS, including the development and application of SAS Macros, coupled with strong programming and problem-solving abilities.
- Have trained or hands-on experience with R Programming.
- Exhibit advanced knowledge of CDISC standards, including CDASH, SDTM, and ADaM.
- Present proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission efforts.
- Display a proven ability to work effectively both independently and within a team, managing personal timelines to achieve set goals.
- Have experience collaborating within cross-functional, multicultural, and international clinical trial teams.
Additional Information
IQVIA is a premier global provider of clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries. We foster intelligent connections to expedite the development and commercialization of groundbreaking medical treatments, ultimately improving patient outcomes and global population health. IQVIA is committed to upholding integrity throughout its hiring process and enforces a strict zero-tolerance policy for candidate fraud. All information and credentials provided must be truthful and complete. Any false statements, misrepresentations, or material omissions discovered during recruitment or employment may lead to immediate disqualification or termination, as per applicable laws. We value your honesty and professionalism.