Senior Principal Statistical Programmer - SAS/R (Remote)

Ethos; Murcia; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) to work fully embedded with a sponsor pharmaceutical client, supported by Cytel. You will lead programming activities for multiple studies with autonomy and expert technical guidance.

Responsibilities include developing SDTM/ADaM specs, SAS programs, high-quality outputs, and overseeing CRO programmers to meet timelines. You will support regulatory submissions and adhere to FDA/ICH guidelines for medical data reporting.

Qualifications

• Bachelor's degree in CS, data science, mathematics or statistics (or related field).
• 7+ years of experience as a Statistical Programmer in biotech/pharma or related biostatistics teams.
• Exceptional SAS programming skills and experience implementing programming procedures in clinical development.
• Extensive experience with CDISC standards.

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 (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 statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines.
• Support the preparation of clinical study reports, regulatory submissions, publications, DSUR, and exploratory analyses.
• Understand and follow FDA regulations which affect the reporting of clinical trial data, including GCP and guidelines for electronic submissions.
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros.
• Participate in the development of CRFs, edit check specifications, and data validation plans.
• Provide review and/or author data transfer specifications for external vendor data.
• Collaborate with internal and external functions to ensure meeting project timelines and goals.
• Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices.

Skills

SAS programming

R programming

CDISC standards

Education

Bachelor's degree in Computer Science / Data Science / Mathematics / Statistics

Tools

SAS

R

Job description

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) to work fully embedded with a sponsor pharmaceutical client, supported by Cytel. You will lead programming activities for multiple studies with autonomy and expert technical guidance.

Responsibilities include developing SDTM/ADaM specs, SAS programs, high-quality outputs, and overseeing CRO programmers to meet timelines. You will support regulatory submissions and adhere to FDA/ICH guidelines for medical data reporting.