Biostatistician

Jobtailor; Acton (MA); On-site; USD 120,000 - 190,000; Full time

Job summary

Jobtailor in Acton, MA seeks a biostatistician to design and analyze clinical trials and observational studies in collaboration with Clinical Operations, Medical Affairs, Regulatory Affairs, and R&D.

You will develop SAPs, perform analyses in SAS, MATLAB, and R, and contribute to protocols, CRFs, and CSRs while ensuring regulatory compliance and supporting submissions and publications.

Qualifications

• Bachelor's degree in Biostatistics, Statistics, or related field.
• ≥5 years of biostatistics experience in medical device or pharmaceutical industry.
• Experience using SAS, MATLAB, and R for analysis.

Responsibilities

• Design and analyze clinical trials and observational studies in collaboration with Clinical Operations, Medical Affairs, Regulatory Affairs, and R&D
• Develop SAPs and perform statistical analyses using SAS, MATLAB, and R
• Provide statistical input for study protocols, CRFs, and CSRs
• Ensure statistical deliverables meet regulatory requirements and industry standards (FDA, EMA, ICH-GCP, ISO)
• Provide data summaries to support data integrity and data review during ongoing studies
• Support regulatory submissions with statistical summaries and responses to agency queries
• Contribute to scientific publications and presentations of clinical data
• Stay current with statistical methodologies and regulatory guidelines relevant to medical devices and diabetes research.
• Performs other duties as required.

Skills

Clinical trial design

Data analysis

Regulatory knowledge

Education

Bachelor's degree in Biostatistics, Statistics, or related field

Tools

SAS

MATLAB

R

Job description

Responsibilities

• Design and analyze clinical trials and observational studies in collaboration with Clinical Operations, Medical Affairs, Regulatory Affairs, and R&D
• Develop statistical analysis plans (SAPs) and perform statistical analyses using SAS, MATLAB, and R
• Provide statistical input for study protocols, case report forms (CRFs), and clinical study reports (CSRs)
• Ensure statistical deliverables meet regulatory requirements and industry standards (FDA, EMA, ICH-GCP, ISO)
• Provide data summaries to support data integrity and data review during ongoing studies
• Support regulatory submissions with statistical summaries and responses to agency queries
• Contribute to scientific publications and presentations of clinical data
• Stay current with statistical methodologies and regulatory guidelines relevant to medical devices and diabetes research.
• Performs other duties as required.

Requirements

• Bachelor's in Biostatistics, Statistics, or a related field
• Minimum of 5 years of experience in biostatistics within the medical device or pharmaceutical industry
• Proficiency in statistical tools, such as SAS, MATLAB, and R for programming and data analysis
• Strong understanding of clinical trial design, data management, and regulatory requirements