Sr. Manager, Biostatistics

Alfasigma; Marbella; Remote; EUR 85,000 - 120,000; Full time

Job summary

Alfasigma is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical clinical development projects. You will be embedded with a sponsor client, supported by Cytel, and lead programming efforts across multiple studies with autonomy and ownership.

The role emphasizes delivering SDTM/ADaM specifications, datasets, and defined reports, while developing complex listings and graphs in SAS and R. CRO oversight is a key responsibility in this senior position.

Qualifications

• Experience leading statistical programming for diverse clinical development programs.
• Ability to oversee CRO programmers and deliver high quality outputs.
• Proven ability to develop SDTM/ADaM specifications and define.xml.
• Strong SAS and/or R programming for reports and graphs.

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 graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs
• Participate in overseeing CROs

Skills

SAS programming

R programming

SDTM/ADaM

CRO oversight

Clinical data analysis

Tools

SAS

R

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