Sr. Manager, Biostatistics

Alfasigma; Santa Cruz de Tenerife; Remote; EUR 60,000 - 90,000; Full time

Job summary

Alfasigma seeks an experienced Senior/Principal Statistical Programmer (SAS + R) for a remote role embedded with a sponsor client. You will develop and maintain SDTM/ADaM datasets, define.xml, and reviewer guides, delivering complex tables and graphs with high quality statistical outputs.

You will work with CROs under limited supervision to ensure timely, compliant results. The position focuses on clinical development programs across multiple studies, requiring strong programming skills and

Qualifications

• Extensive experience using SAS and R for clinical trial programming.
• Delivery of SDTM/ADaM datasets and tables with quality outputs.
• Experience overseeing CROs and ensuring compliant deliverables.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guides and define.xml files for studies.
• Develop SAS programs to produce datasets, listings, tables and graphs.
• Deliver high-quality statistical programming results and maintain SAS/R programs across programs.
• Oversee CROs to ensure consistency and timeliness of data deliveries.

Skills

Statistical programming

SAS

R

Clinical trials

Quality deliverables

Tools

define.xml

ADaM specs

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