Lead Phase I Biostatistician - SAS & Dose-Escalation

Penfield Search Partners Ltd.; Fairfield (CT); À distance; USD 120 000 - 180 000; Plein temps

Résumé du poste

Penfield Search Partners Ltd. seeks a Biostatistician to provide Phase 1 statistical support, lead studies, and deliver high-quality analysis documents for sponsors' programs.

The ideal candidate has strong SAS skills (including TFLs, inferential analyses, and randomization) and can collaborate with the programming team while contributing to SAPs, TFLs, and QC. Experience with first-in-human and dose-escalation studies is highly desirable.

Qualifications

• Phase 1 clinical trial experience is highly desirable.
• Strong SAS programming, including TFLs and SAPs.
• Ability to develop SAPs and TFL shells.
• Regulatory knowledge of FDA/EMA/GCP.

Responsabilités

• Follow SOPs, templates, and policies.
• Develop and QC statistical analyses for trials.
• Develop SAPs and TFL shells.
• Coordinate with internal teams and clients.
• Review protocols and randomization schedules.
• Represent Biostatistics in client and inter-department meetings.

Connaissances

SAS programming

TFLs

Inferential analyses

Randomization

CDISC SDTM

ADaM specs

Pinnacle 21

Cross-functional collaboration

Formation

Master's Degree in Statistics

Outils

Pinnacle 21

Description du poste

Penfield Search Partners Ltd. seeks a Biostatistician to provide Phase 1 statistical support, lead studies, and deliver high-quality analysis documents for sponsors' programs.

The ideal candidate has strong SAS skills (including TFLs, inferential analyses, and randomization) and can collaborate with the programming team while contributing to SAPs, TFLs, and QC. Experience with first-in-human and dose-escalation studies is highly desirable.