Senior Biostatistician — Remote/Hybrid Data & Analysis Leader

ProPharma; Raleigh (NC); Hybrid; USD 90,000 - 130,000; Full time

Job summary

ProPharma is seeking a Biostatistician to lead statistical activities across clinical trials, from study design to reporting, in a collaborative, regulated environment.

The role requires expertise in SAS and R, CDISC SDTM/ADaM, and strong communication to partner with clinical operations, data management, regulatory affairs, and external partners. This is a hybrid Raleigh-based position with some remote days.

Qualifications

• Ph.D. or MS in Biostatistics with strong statistical knowledge.
• 3+ years of relevant work experience in outsourcing.
• Experience in clinical trial design, sample size calculations, and statistical analysis.
• Experience with CDISC data structures (SDTM/ADaM).

Responsibilities

• Lead statistical activities for clinical trials and data analyses, including study design, statistical analysis plan development, and statistical analysis.
• Provide statistical expertise to cross functional teams, including clinical operations, data management, and regulatory affairs.
• Ensure the quality and accuracy of statistical deliverables, including statistical reports, tables, listings, and graphs.
• Participate in the development and review of clinical study protocols and CRFs for appropriate statistical analysis.
• Develop and maintain SAS programs for statistical analysis per SOPs and regulatory guidelines.
• Stay updated with regulatory guidelines and industry standards in biostatistics.
• Contribute to internal processes and SOPs to improve statistical efficiency.
• Provide guidance and mentorship to junior statisticians.
• Other duties as assigned.

Skills

Biostatistics

SAS programming

Project management

Regulatory knowledge

R programming

Education

Ph.D. in Biostatistics

M.S. in Biostatistics

Tools

SAS

R

CDISC SDTM/ADaM

Job description

ProPharma is seeking a Biostatistician to lead statistical activities across clinical trials, from study design to reporting, in a collaborative, regulated environment.

The role requires expertise in SAS and R, CDISC SDTM/ADaM, and strong communication to partner with clinical operations, data management, regulatory affairs, and external partners. This is a hybrid Raleigh-based position with some remote days.