Remote Principal Statistical Programmer Lead

Placements24; Klerksdorp; Remote; ZAR 1,498,000 - 2,163,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely for a sponsor-dedicated setting within one of our pharmaceutical client programs.

You will lead SDTM/ADaM development, write complex SAS/R code, and supervise CRO programmers to ensure high-quality data deliverables in alignment with FDA/ICH regulations. You will contribute to study reports, regulatory submissions, and exploratory analyses, while maintaining strong collaboration with the Director of Biostatistics

Qualifications

• At a minimum bachelor's degree in computer science, data science, mathematics, or statistics major preferred.
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies.
• 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.
• Preferred Qualifications (nice to have): Prior work experience with pharmacokinetic data and the neuroscience field, proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git).

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 complex graphs.
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needs.
• Oversee CRO's 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.
• 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

FDA/ICH regulatory knowledge

Independent work

Leadership

Communication skills

Education

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

Tools

SAS

R

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely for a sponsor-dedicated setting within one of our pharmaceutical client programs.

You will lead SDTM/ADaM development, write complex SAS/R code, and supervise CRO programmers to ensure high-quality data deliverables in alignment with FDA/ICH regulations. You will contribute to study reports, regulatory submissions, and exploratory analyses, while maintaining strong collaboration with the Director of Biostatistics