Senior Signage & Print Designer — Production & Prepress

Direction Design And Print; Málaga; Remote; EUR 70,000 - 100,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote engagement with one of our pharmaceutical clients. You will work independently, manage programming deliverables, and support regulatory submissions while collaborating with CROs and cross-functional teams.

You will develop SDTM/ADaM datasets and complex analyses, ensuring high-quality outputs and adherence to FDA guidelines. This role offers autonomy and a critical impact on trial data analyses.

Qualifications

• Senior-level, independent statistical programming role in pharmacology
• Experience delivering SDTM/ADaM and regulatory submissions
• Ability to oversee CRO programmers and ensure data quality

Responsibilities

• Generate SDTM/ADaM specifications and datasets
• Develop SAS programs for datasets, tables, listings and figures
• Deliver SAS/R programs for clinical development programs
• Oversee CROs to meet timelines and quality standards
• Support clinical study reports, regulatory submissions, publications
• Follow FDA/ICH guidelines for electronic submissions
• Contribute to standards, CRFs, edit checks, and data validation plans
• Collaborate with internal/external teams to meet project goals
• Draft SOPs and work instructions related to programming practices

Skills

Statistical programming

Clinical trial analysis

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 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/or author SOPs and/or Work Instructions related to statistical programming practices

**Here at Cytel we want our employees to succeed