Senior Biostatistician: Clinical Development Lead

Precigen; Germantown (MD); Presencial; USD 170 000 - 185 000; Tempo integral

Resumo da oferta

Precigen, a Nasdaq-listed biopharmaceutical company, seeks a Senior Biostatistician in Germantown, MD to lead statistics for sponsor-sponsored studies from design to interpretation. You will oversee CRO statistics and ensure compliance with sponsor standards, partnering with Clinical Development, Medical Affairs and Regulatory.

You will design analyses for Phase 3b/4 and real-world studies, support publications and regulatory responses, and co-author statistical sections in CSRs and submission

Qualificações

• PhD in biostatistics or statistics; 6+ years in industry preferred.
• MS in biostatistics with 10+ years of experience will be considered.
• Experience across clinical development phases; registrational study or submission experience valued.
• Experience overseeing CRO statistics and programming; SAS/R; CDISC SDTM/ADaM familiarity.

Responsabilidades

• Author or approve statistical sections of protocols, including estimands and endpoints.
• Develop SAPs, TLF shells, and ensure alignment with regulatory questions.
• Advise on endpoint selection, adaptive designs, and multiplicity strategy.
• Oversee CRO biostatistics and programming; SDTM/ADaM specs and deliverables.
• Support data monitoring committees, interim analyses, and unblinding controls.
• Co-author CSRs and regulatory documents; communicate results clearly.
• Design analyses for Phase 3b/4, real-world data, and observational methods.
• Set portfolio statistical standards and SAP templates; collaborate with Data Manager.

Conhecimentos

Statistical analysis

SAS

R

CDISC SDTM/ADaM

Formação académica

PhD in biostatistics or statistics

MS in biostatistics

Ferramentas

SAS

R

Descrição da oferta de emprego

Precigen, a Nasdaq-listed biopharmaceutical company, seeks a Senior Biostatistician in Germantown, MD to lead statistics for sponsor-sponsored studies from design to interpretation. You will oversee CRO statistics and ensure compliance with sponsor standards, partnering with Clinical Development, Medical Affairs and Regulatory.

You will design analyses for Phase 3b/4 and real-world studies, support publications and regulatory responses, and co-author statistical sections in CSRs and submission