Principal Product Manager — Global Platform Solutions

Ingram Micro; Santander; À distance; EUR 75 000 - 110 000; Plein temps

Résumé du poste

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical client projects. You will lead programming efforts across SDTM/ADaM, develop SAS and R code, and ensure high-quality deliverables and regulatory compliance.

You will collaborate with statisticians and CROs, delivering datasets, tables, and figures while supporting regulatory submissions and study reports in a fast-paced environment.

Qualifications

• 10+ years in statistical programming for clinical trials.
• Expertise in SAS and R for programming and data analysis.
• Experience with SDTM/ADaM data structures.

Responsabilités

• Generate SDTM/ADaM specs, datasets, and define.xml for studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality SAS/R programming results for clinical programs.
• Oversee CRO programmers to ensure timely, high-quality deliverables.
• Support preparation of clinical study reports, regulatory submissions and analyses.
• Understand and follow FDA regulations for reporting clinical trial data.
• Contribute to creation and maintenance of documentation.

Connaissances

Statistical programming

SAS programming

R programming

Clinical trials

Regulatory knowledge

Outils

SAS

R

ADaM/SDTM specs

Description du poste

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