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Senior Statistical Programmer
3 weeks ago
This role will be dedicated to one of IQVIA's largest clients through a Functional Service Provider (FSP) type partnership. This means you get all the benefits of working for an industry leading global CRO while operating within a sponsor environment and utilizing sponsor systems. These sponsor clients include world class pharmaceutical and biotech companies offering you a unique opportunity to work on a team where your role is both challenging and rewarding, while working alongside colleagues who are 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
The Senior Statistical Programmer will be responsible for reviewing datasets in submission-ready standard format (ADaM), tables, figures, listings, and submission packages. This individual will provide expertise in the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for all requested analyses.
Main Responsibilities and Accountabilities:
- Collaborates with the study teams to design data structure and specifications for ad hoc and study deliverables including, but not limited to ADaM datasets, Tables, Figures, Listings, and Analysis Submission content.
- Collaborates with study teams to ensure the quality and accuracy - thus submission readiness - of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml).
- Leads and oversees requested efforts for pooled and exploratory analyses working closely with Statistics TA lead and/or study statisticians as well as with clinical programming team and their collection of legacy data.
- Leads and oversees the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures, and listings) when not provided by CRO.
- Leads and oversees the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format.
- Leads and oversees the development of global tools that will increase the efficiency and capacity of the Statistical Programming group.
- Works closely with clinical study teams to plan and execute activities to ensure project timelines are met with high-quality deliverables.
- Collaborates with CR&D staff regarding data analysis requests.
- Performs additional statistical analyses including but not limited to:
- Support responses to regulatory agencies,
- Generate integrated summary of safety and efficacy,
- Support publications and presentations,
- Support planning and reporting of clinical trials via exploratory analyses of available data.
Education:
- BSc in Computer Science, Mathematics, Statistics or related area with relevant experience.
- At least 5+ years of experience in either 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 the SAS software including development and use of SAS Macros. Strong programming and problem-solving skills.
- Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
- Proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities (or equivalent).
- Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
- Experience in working in cross-functional, multicultural, and international clinical trial teams.
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