Principal Statistical Programmer (Remote) - SAS & R

Placements24; East London; Remote; ZAR 1,495,000 - 2,326,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a pharmaceutical client, and supported by Cytel. You will implement reporting and analysis activities for sponsor trials, oversee CROs, and ensure data are delivered to high quality and on time.

The role requires 7+ years in statistical programming, strong SAS, CDISC (SDTM/ADaM/Define.xml), and experience with regulatory submissions. Independent work style and strong communication are essential.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team.
• Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment.
• Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation.
• Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities.
• Must be able to work independently
• Outstanding communication skills (written and verbal) and strong leadership skills.

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 tailored to clinical development programs' needs.
• Oversee CROs\' statistical programming deliverables for multiple clinical studies to ensure high-quality and meet timelines.
• Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses.
• Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice 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 SDTM/ADaM

Define.xml

FDA/ICH regulations

CRO oversight

Leadership

Communication skills

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

SAS

R

Python

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a pharmaceutical client, and supported by Cytel. You will implement reporting and analysis activities for sponsor trials, oversee CROs, and ensure data are delivered to high quality and on time.

The role requires 7+ years in statistical programming, strong SAS, CDISC (SDTM/ADaM/Define.xml), and experience with regulatory submissions. Independent work style and strong communication are essential.