Senior Modern Workplace Architect

Minsait; Vitoria; Remote; EUR 70,000 - 100,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer for a remote role. You will work on clinical development programs, generating SDTM/ADaM datasets and definitions, and delivering high-quality outputs in SAS and R.

You will oversee CRO programmers to ensure timely, accurate results for regulatory submissions and publications. The position reports to Biostatistics and Programming leadership and requires substantial experience with CDISC standards and FDA guidelines, with a high degree of

Qualifications

• Experience designing and delivering SDTM/ADaM specifications and datasets.
• Strong programming skills in SAS and R for clinical trials.
• Familiarity with FDA/good clinical practice guidelines.

Responsibilities

• Generate SDTM and ADaM specifications and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality SAS and R outputs and oversee CRO programmers.
• Support clinical study reports, regulatory submissions, and publications.
• Ensure compliance with regulatory standards and data quality.

Skills

SAS

R

Clinical data analysis

CDISC standards

Tools

SAS Software

R (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 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