Senior Biostatistician - Clinical Trials

Meditrial; Minneapolis (MN); On-site; USD 110,000 - 190,000; Full time

Job summary

Meditrial is seeking an experienced Senior Biostatistician to lead design, analysis, and reporting of clinical trials. You will work with clinical, regulatory, and data management teams to ensure statistical integrity from inception through submission, reporting to the Chief Medical Officer.

The role is office-based in New York City. Responsibilities include guiding Phase I–IV trial design, SAPs, CSR reviews per ICH E9/E9R1, and CDISC SDTM/ADaM data development, with SAS and/or R analyses and

Qualifications

• MSc or PhD in Statistics, Biostatistics, or a closely related discipline.
• Minimum 5 years of experience in clinical trial statistics in pharma/biotech/CRO.

Responsibilities

• Lead statistical design of Phase I–IV trials, including SAPs, protocols, and CSR review.
• Perform/regulatory compliant analyses using SAS or R; ensure accuracy and reproducibility.
• Prepare TLFs for NDA/MAA/IND submissions and provide input to regulatory interactions.
• Collaborate with Data Management and Regulatory Affairs on CDISC datasets (SDTM/ADaM).
• Mentor junior statisticians and contribute to internal statistical standards.

Skills

Statistical analysis

Data interpretation

Regulatory submissions

Mentorship

Education

MSc or PhD in Statistics/Biostatistics

Tools

SAS

R

CDISC

ICH Guidelines (E9,E9R1,E6)

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