Senior Biostatistician

ACL Digital; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

ACL Digital is seeking a Senior Biostatistician in the United States to lead statistical strategy across clinical trials, ensuring robust design, analysis, and interpretation aligned with regulatory standards.

You will partner with Clinical, Data Management, and Regulatory teams to drive data-driven decision making and submission readiness, mentor junior statisticians, and contribute to SOP development and process optimization.

Qualifications

• PhD or Master’s in Biostatistics, Statistics, or related field.
• At least 5 years of clinical trial statistics experience.
• Proficiency in SAS and R with CDISC SDTM/ADaM experience.
• Strong knowledge of ICH-GCP, FDA/EMA guidelines.

Responsibilities

• Design and review SAPs, protocols, and CRFs for Phase I–IV trials.
• Perform statistical analyses in SAS/R with regulatory compliance.
• Lead CDISC datasets and TLFs for CSR and submissions.
• Collaborate to define endpoints, estimands, and interim analyses.
• Provide statistics input for regulatory interactions.
• Mentor junior biostatisticians and aid SOP development.

Skills

Clinical trial statistics

Leadership

Communication

Education

PhD or Master’s in Biostatistics

Tools

SAS

R

CDISC SDTM/ADaM

Job description

The Senior Biostatistician leads statistical strategy and execution across clinical trials, ensuring robust design, analysis, and interpretation aligned with regulatory standards. This role partners cross functionally with Clinical, Data Management, and Regulatory teams to drive data-driven decision making and submission readiness.

Responsibilities

• Design and review statistical analysis plans (SAPs), protocols, and CRFs for Phase I–IV trials
• Perform and oversee statistical analyses using SAS/R, ensuring reproducibility and regulatory compliance
• Lead development of CDISC-compliant datasets (SDTM, ADaM) and TLFs for CSR and regulatory submissions
• Collaborate with cross-functional teams to define endpoints, estimands, and interim analysis strategies
• Provide statistical input for regulatory interactions (e.g., FDA, EMA) and advisory board meetings
• Mentor junior biostatisticians and contribute to SOP development and process optimization

Qualifications

• PhD or Master’s in Biostatistics, Statistics, or related field

Required Skills

• 5+ years of experience in clinical trial statistics, preferably in pharma or CRO
• Proficiency in SAS and R; experience with CDISC standards and regulatory submissions
• Strong understanding of ICH-GCP, FDA/EMA guidelines, and statistical methodologies
• Experience with PK/PD Models in Phase I Study
• Excellent communication and leadership skills