Biostatistician – Clinical Trials Lead & SAP Expert

Penfield Search Partners Ltd.; Fairfield (CT); Remote; USD 120,000 - 180,000; Full time

Job summary

Penfield Search Partners Ltd. is seeking a Biostatistician to apply statistical expertise across multiple clinical research projects, independently supporting or leading studies, performing analyses, and delivering high-quality statistical documents for sponsors' development programs.

Responsibilities include developing SAPs and TFLs, creating randomization schedules, performing QC, and collaborating with cross-functional teams to ensure timely delivery of study outputs in compliance with GCP

Qualifications

• Master’s degree in Statistics, Biostatistics, or related field.
• Experience leading statistical analyses in clinical development.
• Ability to develop SAPs, TFLs, and SAS/R code.
• Knowledge of FDA/EMA guidelines and GCP.

Responsibilities

• Lead statistical analyses for clinical studies and prepare outputs.
• Develop SAPs, TFLs, and safety analyses.
• Collaborate with cross-functional teams and support regulatory submissions.
• Ensure QC and alignment with study protocols and SAPs.

Skills

SAS

R

SAPs

TFL specs

Clinical study design

Education

Master's degree in Statistics/Biostatistics

Tools

SAS

R

CDISC SDTM/ADaM

Job description

Penfield Search Partners Ltd. is seeking a Biostatistician to apply statistical expertise across multiple clinical research projects, independently supporting or leading studies, performing analyses, and delivering high-quality statistical documents for sponsors' development programs.

Responsibilities include developing SAPs and TFLs, creating randomization schedules, performing QC, and collaborating with cross-functional teams to ensure timely delivery of study outputs in compliance with GCP