Senior Statistical Programmer (Remote - Permanent Homebased)

IQVIA, Inc.; England; Remote; GBP 50,000 - 70,000; Full time

Job summary

A leading global clinical research organization is seeking a Senior Statistical Programmer to design and analyze clinical data sets. This role demands 5+ years of experience in statistical programming within the pharmaceutical industry, and strong expertise in SAS software. The position offers home-based work opportunities and a collaborative team environment focused on improving patient outcomes through innovative research.

Benefits

Home-based remote work opportunities

Great work/life balance

Career advancement opportunities

Qualifications

• 5+ years of experience in clinical/statistical programming within CRO/pharmaceutical.
• In-depth understanding of CDISC standards (CDASH, SDTM, ADaM).
• Experience in leading programming activities and meeting timelines.

Responsibilities

• Design data structures and specifications for clinical deliverables.
• Ensure submission readiness of clinical data as required by authorities.
• Lead programming efforts for pooled and exploratory analyses.

Skills

SAS Programming

Statistical Analysis

Clinical Programming Standards

Regulatory Requirements Knowledge

Problem-Solving Skills

Education

BSc in Computer Science, Mathematics, Statistics or related area

Tools

SAS Software

Job description

Overview

Why IQVIA
This role will be dedicated to one of IQVIA's largest clients through a Functional Service Provider (FSP) type partnership. You will get 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 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 plans and executes activities to ensure project timelines are met with high quality deliverables.

Additional tasks

• Collaborates with CR&D staff regarding data analysis requests.
• Performs additional statistical analyses including but not limited to:
• o support responses to regulatory agencies,
• o generate integrated summary of safety and efficacy,
• o support publications and presentations,
• o 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.
• 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections 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