Product And Manufacturing Management (Senior)

Gmv Spain; Madrid; Remote; EUR 65,000 - 90,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on a pharmaceutical client project, delivering high-quality programming for clinical trials.

You will generate SDTM/ADaM datasets, write SAS and R code, supervise CRO programmers, and contribute to regulatory submissions and study reports while ensuring compliance with GCP and FDA guidelines.

Qualifications

• Senior statistical programmer with SAS and R experience.
• Experience with SDTM and ADaM specifications and datasets.
• Oversee CRO programmers and ensure timelines.
• Knowledge of FDA regulations, GCP, and electronic submissions.
• Contribute to study reports, DSURs, and regulatory submissions.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guides and define.xml.
• Develop SAS programs for datasets, complex listings, tables, and graphs.
• Deliver high-quality programming outputs and validate programs.
• Oversee CRO deliverables across studies to meet timelines.
• Support regulatory submissions and clinical study reports.

Skills

SAS

R

SDTM

ADaM

Clinical programming

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