Biostatistician

Job Description: Biostatistician

Job Title

Biostatistician

Department

Biostatistics / Clinical Development

Location

On-site / Hybrid

Job Summary

We are seeking a detail-oriented and motivated Junior Biostatistician to support clinical trial data analysis, statistical programming, and regulatory deliverables under supervision. The role will assist in designing, analyzing, and reporting clinical studies to ensure data integrity, compliance, and accurate statistical interpretation.

Key Responsibilities

- Assist senior statisticians in study design, sample size calculation, randomization, and statistical analysis plan (SAP) development.
- Support data management, data validation, and statistical programming using SAS/R/Python for clinical trial datasets.
- Perform descriptive statistics, safety and efficacy analyses, and generate tables, listings, and figures (TLFs).
- Contribute to clinical study reports (CSRs), interim analysis, and regulatory documents.
- Collaborate with clinical operations, data management, medical, and regulatory teams.
- Ensure compliance with ICH-GCP, FDA/EMA guidelines, and company SOPs.
- Maintain accurate documentation and track project timelines.

Required Qualifications

- Bachelor’s or Master’s degree in Biostatistics, Statistics, Mathematics, Epidemiology, or related quantitative field.
- Basic understanding of clinical trial design, statistical methods, and ICH-GCP principles.
- Working knowledge of statistical software: SAS, R, or Python.
- Strong analytical, problem-solving, and data accuracy skills.
- Good written and verbal communication skills.
- Detail-oriented, organized, and able to work in a team environment.

Preferred Qualifications

- Prior internship or entry-level experience in biostatistics, clinical research, or pharmaceutical industry.
- Experience with CDISC standards (SDTM/ADaM).
- Familiarity with TLF generation and clinical study reporting.
- Basic programming or data analysis portfolio.

What We Offer

- Structured on-the-job training and mentorship.
- Participation in real-world clinical development projects.
- Career growth path to Biostatistician/Senior Biostatistician.
- Competitive compensation and benefits package.