Principal Statistical Programmer – SAS & R (Remote)

Hims & Hers; Santander; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to be fully embedded with a pharmaceutical client.

You will independently drive programming for SDTM/ADaM pipelines, develop complex listings and figures, and oversee CRO deliverables to ensure data quality and timely submissions. You will contribute to regulatory submissions, clinical study reports, and exploratory analyses while adhering to FDA/ICH guidelines and GCP.

Qualifications

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 7+ years as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming and development of SDTM/ADaM/Define.xml.
• Experience supporting regulatory submissions and FDA/ICH guidelines.
• Ability to work independently and lead teams.
• Strong written and verbal communication skills.

Responsibilities

• Generate SDTM and ADaM specifications, datasets, reviewer's guides and define.xml for multiple studies.
• Develop SAS programs to produce datasets, listings, tables, and graphs.
• Deliver high-quality SAS and/or R programs for clinical development programs.
• Oversee CRO programming deliverables to ensure quality and timelines.
• Support creation of clinical study reports, regulatory submissions, publications and DSURs.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with CROs, software vendors, and partners to meet timelines.
• Prepare SOPs and Work Instructions for statistical programming practices.

Skills

SAS programming

R

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Communication

Education

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

Tools

Unix/Linux

Git

Shiny

Python

Java

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to be fully embedded with a pharmaceutical client.

You will independently drive programming for SDTM/ADaM pipelines, develop complex listings and figures, and oversee CRO deliverables to ensure data quality and timely submissions. You will contribute to regulatory submissions, clinical study reports, and exploratory analyses while adhering to FDA/ICH guidelines and GCP.