Senior Principal Statistical Programmer (SAS + R) — Remote

Medical Staff Talent; Málaga; Remote; EUR 70,000 - 90,000; Full time

Job summary

Medical Staff Talent is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical clinical development programs. You will implement reporting and analysis activities, lead SAS and/or R programming efforts, and oversee CRO programmers to ensure high-quality data outputs.

You will collaborate with multiple study teams, contribute to regulatory submissions, and ensure adherence to FDA/ICH regulations.

Qualifications

• Bachelor's degree required in a relevant field such as CS, data science, math or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development.
• Expert SAS programming skills and experience in clinical development environments.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to produce datasets, complex listings, tables, and graphs.
• Deliver high-quality statistical programming results, maintaining SAS and/or R programs.
• Oversee CROs' stats programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Follow FDA regulations and GCP guidelines for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Assist in CRF development, edit checks, and data validation plans.
• Provide review/author data transfer specifications for external vendors.
• Collaborate with CROs, software vendors, and clinical partners to meet project goals.
• Review and/or author SOPs and work instructions for programming practices.

Skills

SAS programming

R programming

CDISC standards

FDA/ICH regulation

Independent work

Education

Bachelor's degree in computer science / data science / mathematics / statistics

Tools

SAS

R

Job description

Medical Staff Talent is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical clinical development programs. You will implement reporting and analysis activities, lead SAS and/or R programming efforts, and oversee CRO programmers to ensure high-quality data outputs.

You will collaborate with multiple study teams, contribute to regulatory submissions, and ensure adherence to FDA/ICH regulations.