Senior Biostatistician: Clinical Trials & SAS Expert

Prometrika, Llc; Cambridge (MA); Sur place; USD 178 000 - 216 000; Plein temps

Résumé du poste

PROMETRIKA is a full-service CRO based in the United States, offering expertise in biostatistics, data management, and regulatory submissions. This role focuses on statistical design, analysis, and CDISC-compliant reporting for diverse clinical trials.

The candidate will lead SAS programming efforts, collaborate with protocol design teams, and guide junior staff while ensuring adherence to GCP/ICH guidelines and regulatory expectations.

Qualifications

• MS in Biostatistics, Mathematics, Statistics, Public Health or related discipline required.
• PhD in Biostatistics, Mathematics, Statistics, Public Health or related discipline preferred.

Responsabilités

• Provide statistical input for protocol development, study design, and CRF development.
• Develop and validate SAS programs to produce/QC statistical tables, analyses, and SDTM/ADaM datasets.
• Oversee production of analysis plans, reports, and regulatory submissions.
• Review and write statistical sections for clinical study reports and publications.
• Lead junior staff and mentor analysts; ensure CDISC data standards compliance.

Connaissances

SAS programming

Statistical analysis

CDISC standards

Data management knowledge

Project leadership

Communication skills

ICH/GCP knowledge

multi-task management

statistical methodology

Formation

MS in Biostatistics/Statistics/Public Health

PhD in Biostatistics/Statistics/Public Health (preferred)

Outils

CDISC SDTM/ADaM tooling

Description du poste

PROMETRIKA is a full-service CRO based in the United States, offering expertise in biostatistics, data management, and regulatory submissions. This role focuses on statistical design, analysis, and CDISC-compliant reporting for diverse clinical trials.

The candidate will lead SAS programming efforts, collaborate with protocol design teams, and guide junior staff while ensuring adherence to GCP/ICH guidelines and regulatory expectations.