Senior Biostatistician

Ephicacy; United States; On-site; USD 90,000 - 140,000; Full time

Job summary

Ephicacy is seeking a senior data reviewer/statistician to oversee cross-functional data transfers and ensure SDTM/ADaM alignment. You will assess study data for completeness, trace data flow from origin to SDTM and ADaM, and provide feedback to study teams for accurate analyses.

Ideal candidates bring advanced training in statistics/biostatistics (PhD or Master’s with extensive experience), strong documentation skills, and hands-on expertise with SAS and/or R.

Qualifications

• PhD or Master’s with required years of experience as specified.
• Experience reviewing data and SDTM/ADaM knowledge.
• Ability to document findings clearly and follow up to resolution.
• Strong analytical skills and meticulous data review approach.

Responsibilities

• Review and supervise external data transfers for completeness, consistency, and alignment with specs.
• Review external data and study documentation for accuracy, quality, and readiness for analysis.
• Trace data flow and programming logic from source to SDTM and from SDTM to Adam to support review and validation.
• Review SDTM and Adam specifications, tables, listings, figures, SAPs, amendments, and study documentation.
• Conduct routine study data review to identify inconsistencies or missing data affecting analysis.
• Validate statistical outputs and provide documentation to ensure reproducibility and transparency.

Skills

Collaboration

Documentation

SDTM/ADaM knowledge

Data review

Analytical skills

Attention to detail

SAS

R

Education

PhD in statistics/biostatistics or related with 3+ years experience

Master’s degree with 6+ years experience

Tools

SAS

R

CDISC SDTM/ADaM

Job description

Below are the key responsibilities, core competencies, and education needed for this role.

Responsibilities

• Review and supervise external data transfers to ensure completeness, consistency, and alignment with specifications.
• Review external data and study documentation for accuracy, quality, and readiness for analysis.
• Trace data flow and programming logic from source data to SDTM and from SDTM to Adam to support review and validation.
• Review and provide feedback on SDTM and Adam specifications, tables, listings, figures, statistical analysis plans, protocol amendments, and relevant study documentation.
• Conduct routine study data review to identify inconsistencies, missingness, or other issues that may affect analysis or interpretation.
• Validate statistical outputs, provide independent documentation to ensure results are reproducible and transparent.

Qualifications

Education - PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years relevant work experience, or a Master’s degree with a minimum of 6 years relevant work experience.

Required Skills

• Collaborate with a cross-functional study team and external vendors to resolve data issues.
• Document review findings clearly and follow up through resolution.
• Working knowledge of CDISC standards, including SDTM and Adam.
• Strong documentation and written communication skills.
• Strong analytical skills and a careful, methodical approach to data review.
• Reliable, detail-oriented, and able to identify issues and provide thoughtful, practical feedback.
• Solid knowledge of statistical analysis methodologies and experimental design.
• Working knowledge of statistical and data processing software e.g. SAS and/or R.