Product Manager

Comexi Group Industries S.A.U; Gerona; Remote; EUR 75,000 - 115,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work with sponsor clients in a fully embedded role, backed by Cytel expertise. You will implement reporting and analysis activities for multiple clinical trials and oversee CRO programmers to ensure consistent, high-quality data deliverables.

The role focuses on SAS and R programming for SDTM/ADaM, regulatory submissions, and exploratory analyses, with emphasis on GCP and FDA guidelines for electronic submissions.

Qualifications

• Experience in clinical development programming.
• Proficient in SAS and R.
• Knowledge of SDTM/ADaM standards.

Responsibilities

• Generate SDTM and ADaM specifications, datasets, reviewers' guides and define.xml.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality SAS and R programs for clinical development programs.
• Oversee CRO programmers to ensure timely, high-quality deliverables.
• Support preparation of CSR, regulatory submissions, DSUR, and exploratory analyses.
• Ensure compliance with FDA regulations, GCP, and electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide review and quality assurance of programming outputs.

Skills

SDTM/ADaM

CRO oversight

Regulatory submissions

Tools

SAS

R

Job description

Senior/Principal Statistical Programmer SAS + R (Remote)

Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Position Overview: This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.

As a Principal Statistical Programmer, your responsibilities will include:

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needs
• Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
• Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
• Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in the development of CRFs, edit check specifications, and data validation plans
• Provide review