Metge/Ssa Especialista En Psiquiatria

Althaia, Xarxa Assistencial Universitària De Manresa; Badalona; Remote; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on one or more pharmaceutical client programs. You will develop SDTM/ADaM specifications, write SAS and R code, and oversee CRO programmers to ensure high-quality data deliverables. You will support regulatory submissions and study reports, with adherence to FDA guidelines.

The role requires expert technical skills, strong independence, and experience in clinical development across therapeutic areas.

Qualifikationen

• Senior-level statistical programmer familiar with clinical development programs.
• Strong knowledge of SAS and/or R for complex analyses.
• Experience delivering SDTM and ADaM datasets and define.xml files.
• Ability to oversee CRO programmers and ensure timely, high-quality outputs.
• Understanding of FDA regulations for reporting clinical trial data.

Aufgaben

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml for multiple studies.
• Develop SAS programs to create datasets, tables, listings, and graphs.
• Deliver high-quality SAS and/or R analyses tailored to clinical development needs.
• Oversee CRO programming deliverables across studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications and DSUR.

Kenntnisse

SAS

R

SDTM/ADaM specifications

Statistical programming

CRO oversight

Regulatory submissions support

Tools

SAS

R

Jobbeschreibung

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