Strategy & Development Senior Associate

Hipoges Iberia; España; Remote; EUR 90,000 - 120,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor, embedded within a pharmaceutical client. You will lead programming tasks across studies, ensure data quality, and support regulatory submissions while guiding CRO work to high standards.

The role emphasizes independent work, adherence to FDA guidelines, and the development of reusable programming standards for future trials.

Qualifications

• Extensive experience as Principal Statistical Programmer in clinical development.
• Proven ability to deliver SDTM/ADaM specifications and datasets for multiple studies.
• Knowledge of FDA regulations, GCP, and electronic submissions guidance.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guides, and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality SAS and/or R programs for clinical development programs.
• Oversee CROs' statistical programming deliverables across studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, DSUR, and exploratory analyses.
• Comply with FDA regulations affecting reporting of trial data and electronic submissions.
• Contribute to creating and maintaining standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specifications, and data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with internal/external functions to meet project timelines.

Skills

SAS

R

SDTM

ADaM

Clinical trial programming

CRO oversight

Regulatory submissions

Data analysis

Tools

SAS software

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 and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
• Provide review and