Principal Biostatistician — Clinical Development Lead

Precigen, Inc; Germantown (MD); Presencial; USD 190 000 - 215 000; Tempo integral

Resumo da oferta

Precigen, Inc. in Germantown, MD is seeking a Principal Biostatistician to serve as the sponsor's statistical lead for all company-sponsored studies across Clinical Development and Medical Affairs.

Responsibilities include owning statistical design and analysis, overseeing CRO statistics and programming teams, contributing to regulatory documents, and guiding analyses for Phase 3b/4 and real-world studies, with emphasis on ICH guidance and regulatory collaboration.

Qualificações

• PhD in biostatistics or statistics with 10+ years or MS with 14+ years.
• Experience across clinical development phases; registrational study/submission experience strongly preferred.
• Experience overseeing CRO statistics and programming; working knowledge of SAS and/or R and CDISC SDTM/ADaM.
• Knowledge of ICH E9 and E9(R1), FDA and EMA statistical guidance; real-world evidence or observational methods experience valued.
• Clear communicator with non-statisticians, including executives and regulators.

Responsabilidades

• Author or approve statistical sections of protocols and amendments: endpoints, estimands, sample size, and randomization.
• Author or approve statistical analysis plans and TLF shells; ensure analyses align with questions.
• Advise on endpoint selection, adaptive/interim designs, and multiplicity strategy.
• Oversee CRO biostatistics and programming: SDTM/ADaM specifications, define.xml, validation, TLF delivery.
• Contribute to vendor selection and scope; review change orders for statistical work.
• Support data monitoring committees and interim analyses with proper governance.
• Interpret and present results; co-author CSRs and regulatory documents.
• Design analyses for Phase 3b/4, registry, real-world studies with observational methods.

Conhecimentos

Statistical leadership

Communication skills

Cross-functional collaboration

Regulatory knowledge

Formação académica

PhD in biostatistics

MS in biostatistics

Ferramentas

SAS

R

CDISC SDTM/ADaM

Descrição da oferta de emprego

Precigen, Inc. in Germantown, MD is seeking a Principal Biostatistician to serve as the sponsor's statistical lead for all company-sponsored studies across Clinical Development and Medical Affairs.

Responsibilities include owning statistical design and analysis, overseeing CRO statistics and programming teams, contributing to regulatory documents, and guiding analyses for Phase 3b/4 and real-world studies, with emphasis on ICH guidance and regulatory collaboration.