Biostatistician (Medtech)

TL;DR

Biostatistician (Medtech): Designing and executing statistical analysis for clinical trials within the biotech and pharmaceutical sectors with an accent on protocol adaptation and CDISC standards. Focus on developing statistical analysis plans, performing sample size calculations, and producing high-quality TLFs and CSRs.

Location: United States. Remote and hybrid options available.

Company

An end-to-end consulting provider for biotech, med device, and pharmaceutical organizations across the complete product lifecycle.

What you will do

• Develop and adapt statistical analysis plans (SAP) and shells from study protocols.
• Perform and quality-control sample size calculations and randomization specifications.
• Create and review SDTM and ADaM domains and mapping algorithms according to CDISC standards.
• Produce and review datasets, listings, tables, and graphs (TLFs) per the SAP.
• Review the statistical sections of Clinical Study Reports (CSR) for accuracy.
• Collaborate with cross-functional teams and external clients on project issues.

Requirements

• Advanced degree (MS or PhD) in Statistics or a closely related field.
• 2-4 years of experience in clinical trials design and analysis.
• Proficiency in statistical programming using SAS or R.
• Working knowledge of CDISC standards and their application to projects.
• Excellent English communication skills.

Culture & Benefits

• Support for remote working with encouraged hybrid flexibility for those near offices.
• Commitment to diversity, equity, and inclusion.
• Culture of authenticity, innovation, and entrepreneurial spirit.
• Personal review of all applications by the recruitment team without the use of AI screening tools.