Senior Statistical Programmer - FSP

Description

The company runs clinical trials and needs a senior statistical programmer to lead SAS programming work on submission-ready datasets, tables, figures, listings and submission packages.

The role covers the design, build and quality control of SAS programs that access, extract, transform, review, analyse and submit clinical data.

The position is offered as a functional service provision (FSP) engagement.

Responsibilities

• Work with study teams to define data structures and specifications for ad hoc and study outputs, including ADaM datasets, tables, figures, listings and analysis submission content.
• Check that clinical data meets regulatory requirements and is ready for submission, covering SDTM, ADaM, tables, figures, listings and define.xml.
• Lead and oversee pooled and exploratory analyses with the Statistics TA lead, study statisticians and the clinical programming team, including their legacy data.
• Lead the in-house specification and delivery of ISS and ISE datasets and their tables, figures and listings where a CRO does not provide them.
• Lead the design and build of complex SAS programs that analyse and report complex trial data in CDISC ADaM format.
• Lead the creation of global tools that make the statistical programming group more efficient and able to take on more work.
• Plan and carry out work with clinical study teams so that deadlines are met and deliverables are of high quality.
• Support CR&D staff with data analysis requests.
• Carry out further statistical analyses, such as supporting regulatory agency responses, producing integrated safety and efficacy summaries, supporting publications and presentations, and supporting trial planning and reporting through exploratory analysis of available data.

Requirements

• A BSc in Computer Science, Mathematics, Statistics or a related field, plus relevant experience.
• At least 5 years of experience in clinical programming, statistical programming or both, within a CRO or pharmaceutical setting.
• In-depth knowledge of clinical and statistical programming processes and standards.
• Extensive SAS programming experience, including writing and using SAS macros, with strong programming and problem-solving skills.
• Hands-on R programming experience. This is mandatory.
• Advanced knowledge of CDISC standards, including CDASH, SDTM and ADaM.
• Proven experience leading programming work on pooled and exploratory analyses across several studies and submissions, or equivalent experience.
• Ability to work alone or in a team and to manage your own timelines to meet goals.
• Experience working in cross-functional, multicultural and international clinical trial teams.

Conditions

The role is a functional service provision (FSP) position.

Equal opportunity statement: the company values diversity and welcomes applications from all backgrounds.