Senior Statistical Programmer Remote: Lead & Deliver

Picknpay

South Africa

Remote

ZAR 900,000 - 1,300,000

Full time

4 days ago
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Job summary

Cytel Inc. is recruiting a Senior/Principal Statistical Programmer to work remotely with a premier pharmaceutical client. The role emphasizes SAS programming, SDTM/ADaM, Define.xml, and regulatory submissions, with CRO oversight and high-quality data delivery.

You will contribute to CRFs, data validation, eSubmissions, and DRR/DSUR activities while collaborating across global teams under FDA/ICH guidelines.

Qualifications

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

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 studies to ensure high quality and timelines.
  • Support preparation of clinical study reports, regulatory submissions, publications, DSURs, and exploratory analyses.
  • Understand and follow FDA regulations affecting reporting of clinical trial data (GCP, eSubmissions).
  • Contribute to creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros.
  • Develop CRFs, edit check specs, and data validation plans.
  • Provide review/author data transfer specifications for external vendor data.
  • Collaborate with internal/external functions to meet timelines and goals.
  • Provide review/author SOPs and work instructions for statistical programming practices.
  • Here at Cytel we want our employees to succeed and we enable this success through training and support.
  • To be successful you will have: 7+ years experience, SAS, CDISC, FDA/ICH, independence, leadership.

Skills

SAS programming
Independent worker
Communication skills
Leadership
R
Python
Java
Shiny
Unix/Linux
Git

Education

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

Tools

SAS
R
Python
Java
Shiny
Unix/Linux
Git

Job description

Cytel Inc. is recruiting a Senior/Principal Statistical Programmer to work remotely with a premier pharmaceutical client. The role emphasizes SAS programming, SDTM/ADaM, Define.xml, and regulatory submissions, with CRO oversight and high-quality data delivery.

You will contribute to CRFs, data validation, eSubmissions, and DRR/DSUR activities while collaborating across global teams under FDA/ICH guidelines.

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