Sr. Manager, Biostatistics

Alfasigma; Córdoba; Remote; EUR 65,000 - 90,000; Full time

Job summary

Alfasigma is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-driven clinical trials. You will develop SAS and R programs, define data standards (SDTM/ADaM) and review define.xml files, while guiding CRO programming activities.

The role requires senior-level expertise in clinical statistics programming, data management, and the ability to work autonomously within a global team.

Qualifications

• Extensive experience in clinical programming and data standards (SDTM/ADaM).
• Proficiency in SAS programming for datasets, listings, tables and graphs.
• Experience overseeing CROs or external vendors is a plus.

Responsibilities

• Generate SDTM/ADaM specifications and define.xml files for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables and graphs.
• Deliver high-quality programming outputs for sponsor trials and ensure consistency across studies.
• Oversee CRO programmers to ensure timely, compliant data delivery.

Skills

SAS

R

SDTM

ADaM

define.xml

listing

graphs

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