Principal Statistical Programmer FS...

About the Role

As a Principal Statistical Programmer fully embedded within one of our global pharmaceutical clients’ programs with Cytel support, you will be at the heart of innovation. You are expected to work autonomously and own your deliverables for next-generation patient treatments.

Position Overview

This role reports to the Director, Biostatistics and Programming within the FSP Services business unit in Cytel. As a Principal Statistical Programmer:

• You will operate independently with minimal supervision, tracking progress effectively.
• You will provide expert technical support to team members.
• Our ideal candidate is a highly experienced senior statistical programmer capable of working across diverse therapeutic areas and overseeing other programmers to ensure high-quality data summaries consistent with pre-specified timelines.

Key Responsibilities

Your responsibilities include:

• Generating SDTM, ADaM specifications, datasets, reviewer’s guides, and define.xml files for multiple studies.
• Developing SAS programs to generate complex listings, tables (including descriptive and inferential statistics), and sophisticated graphs in collaboration with statisticians.
• Delivering high-quality statistical programming results by developing, validating, and maintaining tailored SAS and/or R programs for clinical development needs.
• Oversight of CRO’s deliverables to ensure quality and timeliness across multiple studies.
• Supporting the preparation of Clinical Study Reports (CSRs), regulatory submissions, publications, annual DSURs, and exploratory analyses.
• Maintaining expertise in FDA regulations affecting clinical trial data reporting, including Good Clinical Practice (GCP) guidelines for electronic submissions.
• Contributing to standards creation, maintenance, documentation, and validation of programming tools, outputs, and macros.
• Developing CRFs, edit check specifications, and data validation plans.
• Authoring or reviewing data transfer specifications for external vendor data.
• Collaborating with internal/external functions (CROs, software vendors, clinical partners) to meet project goals.
• Contributing to SOPs and Work Instructions related to statistical programming practices.