Principal Statistician (Biostatistics)

TL;DR

Principal Statistician (Biostatistics): Leading statistical design and analysis for oncology clinical trials with an accent on study design, sample size calculations, and regulatory reporting. Focus on authoring Statistical Analysis Plans (SAPs), ensuring CDISC standards compliance, and providing statistical interpretation for clinical study reports.

Location: Shanghai, China

Company

hirify.global is a biopharmaceutical company developing novel therapeutic candidates to significantly improve quality of life and survival for people with cancer.

What you will do

• Serve as the lead statistician on clinical study teams, providing expertise for study design and sample size calculations.
• Independently author Statistical Analysis Plans (SAPs) and integrated safety/efficacy summaries (ISS/ISE).
• Write and review statistical method sections for Clinical Study Reports (CSRs) to ensure scientific rigor.
• Drive the adoption of innovative statistical methodologies tailored to specific project needs.
• Collaborate with regulatory agencies and provide statistical support for medical publications.

Requirements

• Ph.D. or MS in Statistics, Biostatistics, or a related discipline.
• At least 5 years of experience in clinical development within the Pharmaceutical or Biotechnology industry.
• Deep understanding of global clinical trial methodologies, CDISC standards (SDTM and ADaM), and ICH/GCP guidelines.
• Fluent English (both written and verbal) is required.
• Must be based in Shanghai, China.

Nice to have

• Experience in oncology-related clinical trials.

Culture & Benefits

• Competitive base salary, annual performance-based bonus, and equity plans.
• Generous leave policy with up to 15 OPT and 12 sick days annually.
• Excellent medical coverage.
• Social Security and Provident Fund contributions.