Description
Job Location: Reading, UK
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level
Why IQVIA
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
Job Description
The Senior Statistical Programmer will be responsible for review 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 or study statisticians as well as with clinical programming team their collection of legacy data.
- Leads oversees in-house specification delivery ISS ISE datasets associated output (tables figures listings) when not provided by CRO.
- Leads oversees design implementation complex SAS programs applications designed analyze report complex clinical trial data CDISC ADaM format.
- Leads oversees development global tools increase efficiency capacity Statistical Programming group.
- Works closely with clinical study teams plans executes activities ensure project timelines met high quality deliverables.
Additional Tasks
Collaborates with CR&D staff regarding data analysis requests. Performs additional statistical analyses including but not limited to:
- support responses regulatory agencies,
- generate integrated summary safety efficacy,
- support publications presentations,
- support planning reporting clinical trials via exploratory analyses available data,
Position Qualifications And Experience Requirements
Education
BSc in Computer Science Mathematics Statistics or related area relevant experience
Experience
At least 5+ years experience either clinical programming/or statistical programming within CRO/pharmaceutical environment using SAS Software.
In-depth understanding clinical programming/or statistical programming processes standards.
In-depth understanding regulatory requirements relevant statistical programming (e.g., GCP ICH).
Extensive experience statistical programming using SAS software including development use SAS Macros.
Strong programming problem-solving skills.
Advanced knowledge CDISC standards (CDASH SDTM ADaM).
Proven experience leading programming activities pooled exploratory analyses across multiple clinical studies submission activities or equivalent.
Proven ability work effectively both independently or team setting meet set goals managing own timelines.
Experience working cross-functional multicultural international clinical trial teams.
IQVIA is a leading global provider of clinical research services commercial insights healthcare intelligence life sciences healthcare industries. We create intelligent connections accelerate development commercialization innovative medical treatments help improve patient outcomes population health worldwide.
Learn more at https://jobs.iqvia.com
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