Senior Biostatistician - Clinical Trials

Meditrial; New York (NY); On-site; USD 140,000 - 190,000; Full time

Job summary

Meditrial is seeking an experienced Senior Biostatistician for its New York City office. You will design, analyze, and report on clinical trials, collaborating with clinical, regulatory, and data management teams to maintain statistical integrity from study inception to submission.

You will work closely with the Chief Medical Officer, lead Phase I–IV design strategies, author SAPs and study reports, and ensure regulatory compliance with ICH/CDISC guidelines.

Qualifications

• Masters or PhD in statistics/biostatistics or a closely related discipline.
• Minimum 5 years of clinical trial statistics experience.
• Proficiency in SAS (Base/STAT/MACRO) and/or R.
• Strong knowledge of ICH guidelines (E9, E9(R1), E6 GCP) and CDISC standards.
• Proven experience contributing to regulatory submissions.

Responsibilities

• Lead the statistical design of Phase I–IV clinical trials, including sample size calculations, randomisation schemes, and adaptive design strategies.
• Author and review SAPs, protocols, and clinical study reports per ICH guidelines.
• Perform and oversee statistical analyses using SAS, R, or equivalent; ensure accuracy and regulatory compliance.
• Prepare and review TLFs for NDA, MAA, IND submissions.
• Provide statistical input to regulatory interactions (FDA/EMA) and respond to queries.
• Collaborate on CRF design, data validation, and CDISC-compliant datasets (SDTM, ADaM).
• Mentor junior statisticians and promote scientific rigour.
• Contribute to internal statistical standards and process improvements.

Skills

SAS

R

Statistical design

Regulatory submissions

Mentoring

Education

MSc/PhD in Statistics/Biostatistics

Tools

CDISC SDTM/ADaM

Job description

We are looking for an experienced Senior Biostatistician to join our team and play a pivotal role in the design, analysis, and reporting of clinical trials. You will work closely with clinical, regulatory, and data management teams to ensure the statistical integrity of our studies from inception through to submission. The profile will work in close contact with and report to the Chief Medical Officer. The position is to be considered office-based (New York City)

Responsibilities

• Lead the statistical design of Phase I–IV clinical trials, including sample size calculations, randomisation schemes, and adaptive design strategies
• Author and review Statistical Analysis Plans (SAPs), protocols, and clinical study reports in line with ICH E9 and E9(R1) guidelines
• Perform and oversee statistical analyses using SAS, R, or equivalent software, ensuring accuracy, reproducibility, and regulatory compliance
• Prepare and review tables, listings, and figures (TLFs) for regulatory submissions (NDA, MAA, IND)
• Provide statistical input to regulatory authority interactions, including responses to queries from the FDA, EMA, and other agencies
• Collaborate with Data Management and Regulatory Affairs on CRF design, data validation, and CDISC‑compliant datasets (SDTM, ADaM)
• Mentor and guide junior statisticians, fostering a culture of scientific rigour and continuous learning
• Contribute to process improvement initiatives and the development of internal statistical standards

Qualifications & Personal Skills

• MSc or PhD in Statistics, Biostatistics, or a closely related discipline
• Minimum 5 years of experience in clinical trial statistics within a pharmaceutical, biotech, or CRO environment
• Strong proficiency in SAS (Base, STAT, MACRO) and/or R
• Solid working knowledge of ICH guidelines (E9, E9(R1), E6 GCP) and CDISC standards
• Proven experience contributing to regulatory submissions

Preferred Qualifications

• Experience with adaptive or Bayesian trial designs
• Familiarity with estimands framework (ICH E9(R1))
• Exposure to therapeutic areas such as oncology, cardiovascular, or rare diseases
• Experience in mixed or medical device / combination product trials is a plus