At a Glance
- Tasks: Review and analyse clinical data, ensuring submission readiness and quality control.
- Company: Leading pharmaceutical company with a focus on innovation and collaboration.
- Benefits: Home-based work, job stability, and opportunities for professional growth.
- Other info: Collaborate with industry leaders across diverse therapeutic areas.
- Why this job: Join a dynamic team and make a real impact in clinical research.
- Qualifications: 5+ years in statistical programming with SAS; strong problem-solving skills.
The predicted salary is between 60000 - 75000 £ per year.
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
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 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.
- Extensive experience with statistical programming using the SAS software including development and use of SAS Macros.
- Strong programming and problem-solving skills.
- Good experience in R Programming (Trained/Hands on experience)
- 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.
Additional Benefits
- Home-based remote work opportunities
- 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
Senior Statistical Programmer (FSP - Permanent Homebased) employer: IQVIA Argentina
As a Senior Statistical Programmer at our company, you will enjoy the flexibility of permanent home-based work while collaborating with industry leaders in the Pharma and CRO sectors. Our cohesive team environment fosters collaboration and innovation across various therapeutic areas, ensuring job stability and ample opportunities for professional growth and development.
We think you need these skills to ace Senior Statistical Programmer (FSP - Permanent Homebased)
SAS Programming
ADaM
CDISC Standards
Statistical Analysis
Data Structure Design
Quality Control
SAS Macros
