Senior Biostatistician - Remote/On-site Clinical Trials Lead

Planet Pharma; New Jersey; Hybrid; USD 120,000 - 170,000; Full time

Job summary

Planet Pharma seeks a Senior Biostatistician for our Bridgewater, NJ or remote work from anywhere in the USA. You will lead statistical planning, analysis, and reporting for pivotal clinical trials, and contribute to SAPs, data standards, and publication efforts.

The role requires advanced biostatistics expertise, project leadership, and collaboration with data management to ensure high-quality deliverables and timely CSR submissions.

Qualifications

• PhD in statistical science or related field with 2 years relevant experience, or a Master’s with 4 years relevant experience.
• Strong background in statistical methods for design, analysis and reporting of clinical trials.
• Experience writing SAPs and contributing to protocol sections.

Responsibilities

• Lead statistical and programming operations to ensure quality and on-time delivery.
• Provide statistical design, analysis and reporting for clinical trials and research projects.
• Write SAPs and manage QC/QA plans for projects.
• Develop ADaM dataset specifications and review SDTM specifications.
• Perform data validation and prepare statistical reports for CSR and publications.
• Collaborate with data management and trial teams to ensure data quality and timely database lock.

Skills

Leadership

Project management

Statistical analysis

Biostatistics

Clinical trial design

SAP writing

Education

PhD in statistical science or related field

MS in statistics or related field

Tools

SAS

R

ADaM

SDTM

Job description

Planet Pharma seeks a Senior Biostatistician for our Bridgewater, NJ or remote work from anywhere in the USA. You will lead statistical planning, analysis, and reporting for pivotal clinical trials, and contribute to SAPs, data standards, and publication efforts.

The role requires advanced biostatistics expertise, project leadership, and collaboration with data management to ensure high-quality deliverables and timely CSR submissions.