Sr. Manager, Biostatistics

Alfasigma; Vitoria; Remote; EUR 55,000 - 90,000; Full time

Job summary

Cytel offers a Senior/Principal Statistical Programmer role focused on delivering end-to-end programming for sponsor-driven clinical trials. You will work remotely within a globally distributed team, ensuring SDTM/ADaM compliance and high-quality outputs while collaborating with statisticians and CROs.

The position requires extensive experience in SAS and R, with a focus on delivering datasets, listings, tables, and graphics for multiple studies.

Qualifications

• Experience in clinical programming for sponsor CRO projects.
• Proficient in SDTM/ADaM specifications.
• Ability to deliver high-quality outputs with minimal supervision.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables, and complex graphs in collaboration with a Statistician
• 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 CROs

Skills

SAS

R

Clinical programming

CRO oversight

Tools

SAS Software

R Software

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