Senior Biostatistician (Pharmaceuticals)

TL;DR

Senior Biostatistician (SAS/Pharma): Developing and reviewing statistical analysis plans and datasets for clinical trials with an accent on regulatory submission and clinical endpoint analysis. Focus on ensuring SAP consistency, validating ADaM datasets, and preparing high-quality statistical reports for pharmaceutical and biotech clients.

Location: Home Based (South Africa)

Company

hirify.global is an award-winning, data-focused clinical research organization (CRO) supporting the pharmaceutical, biotech, and medical device industries.

What you will do

• Develop and review statistical analysis plans (SAP) and provide advanced input into clinical study protocols.
• Perform senior-level reviews of datasets and outputs to ensure consistency with the SAP and overall quality.
• Collaborate with programming teams to define analysis/ADaM datasets and prepare TLG shells and specifications.
• Coordinate the execution, reporting, and documentation of high-quality statistical analysis.
• Prepare statistical methods and results sections for clinical study reports (CSR) in collaboration with medical writers.
• Support Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.

Requirements

• MSc in Statistics (5+ years experience) or PhD (2+ years experience).
• Must be based in South Africa.
• Strong proficiency in SAS (SAS Stat, Base, macros, ODS, Graph).
• Deep knowledge of study designs and statistical methods (GLMs, non-parametric, survival analysis).
• Working knowledge of SDTM/ADaM standards and experience with EDC systems.
• At least 3 years of professional experience in the pharmaceutical industry.

Culture & Benefits

• Great Place to Work certified organization with an exceptional culture.
• Industry-leading employee retention rate.
• Collaborative and inclusive work environment.
• Opportunity to work within a global footprint spanning four continents.