Senior Care Rn — Night Shift, Prn

Johnson Regional Medical Center; Pedrafita do Cebreiro; Remoto; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

Johnson Regional Medical Center is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-driven clinical trials. The role focuses on delivering high-quality programming for SDTM/ADaM and regulatory submissions.

You will lead SAS and R programming, oversee CRO outputs, and ensure data standards are maintained across studies, with minimal supervision and close collaboration with statisticians.

Competenze

• Extensive experience in clinical trial programming.
• Proficient in SDTM/ADaM data structures and specifications.
• Experience coordinating CROs and regulatory deliverables.

Mansioni

• Generate SDTM/ADaM specs and datasets for studies.
• Develop SAS and R programs for listings, tables and figures.
• Lead CRO programming deliverables and ensure timelines.
• Support clinical study reports and regulatory submissions.
• Ensure compliance with GCP and FDA electronic submission guidelines.
• Create and validate programming standards and macros.

Conoscenze

SAS programming

R programming

Clinical data analysis

CRO oversight

Strumenti

SDTM

ADaM

define.xml

Descrizione del lavoro

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