Senior Biostatistician

Ephicacy; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Ephicacy seeks a Biostatistician to provide statistical expertise for oncology clinical trial projects, ensuring accuracy, quality, and reproducibility of statistical deliverables. You will collaborate with study teams and functional partners to drive analyses and interpretation.

The role requires PhD or MSc in Statistics/Biostatistics and hands-on experience with Phase II/III oncology trials, CDISC SDTM/ADaM, and proficiency in SAS or R.

Qualifications

• Hands-on support for oncology Phase II/III trials.
• Strong knowledge of event-driven analyses and endpoints.
• CDISC SDTM/ADaM expertise and clinical trial documentation.
• Proficiency in SAS and/or R for programming and data processing.
• Solid understanding of statistical methods and experimental design.

Responsibilities

• Support statistical analyses of oncology endpoints and event-driven analyses.
• Perform event projections to estimate timelines for analyses.
• Review SDTM/ADaM specs, TLFs, SAPs, and trial docs.
• Identify data inconsistencies and patterns in study data reviews.
• Validate outputs and maintain quality control documentation.
• Collaborate with biostatistics, programming, and study teams.

Skills

Phase II/III oncology trials

Event-driven analyses

CDISC SDTM/ADaM

SAS and/or R

Statistical methodologies

Documentation & cross-functional coll.

Education

PhD in Statistics/Biostatistics/related

Master’s in Statistics/Biostatistics/related

Tools

SAS

R

Job description

Biostatistician will provide statistical expertise and operational support for oncology clinical trial projects, with responsibility for ensuring the accuracy, quality, and reproducibility of statistical deliverables. The role requires strong oncology clinical trial experience, working knowledge of CDISC standards, and the ability to collaborate effectively with internal study teams and relevant functional partners, as applicable.

Key Responsibilities:

• Support statistical analyses of oncology endpoints, including time-to-event and response-based endpoints.
• Perform event projections to estimate timelines for planned event-driven analyses.
• Review SDTM/Adam specifications, tables, listings, figures (TLFs), Statistical Analysis Plans (SAPs), and clinical trial documentation.
• Conduct clinical study data reviews to identify inconsistencies, missing data, and unexpected patterns.
• Validate statistical outputs and maintain documentation to support quality control and reproducibility.
• Collaborate with biostatistics, statistical programming, clinical study teams, and other functional partners to resolve data and analysis-related issues.

Required Skills & Experience:

• Hands-on experience supporting Phase II and Phase III oncology clinical trials.
• Strong understanding of event-driven analyses, time-to-event endpoints, and response-based endpoints.
• Working knowledge of CDISC standards, including SDTM and Adam.
• Proficiency in SAS and/or R for statistical programming and data processing.
• Solid understanding of statistical methodologies and experimental design.
• Strong analytical, documentation, communication, and cross-functional collaboration skills.

Education & Experience:

• PhD in Statistics, Biostatistics, or a related discipline or
• Master’s degree in Statistics, Biostatistics, or a related discipline