Senior Biostatistician – Clinical Development & Regulatory

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

Resumo da oferta

Precigen, Inc. is seeking a Senior Biostatistician to lead sponsor-driven statistics across Clinical Development and Medical Affairs, partnering with Clinical Development, Medical Affairs and Regulatory to ensure robust study design and analysis.

The role requires directing CRO biostatistics, overseeing SDTM/ADaM workflows, and guiding endpoint selection, adaptive designs, and regulatory reporting with strong communication to stakeholders.

Qualificações

• PhD in biostatistics or statistics with 6+ years of industry experience, or MS with 10+ years.
• Experience across clinical development phases; registrational study or 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: objectives, estimands (ICH E9(R1)), endpoints, sample size and randomization.
• Author or approve statistical analysis plans and TLF shells; ensure analysis is aligned to the scientific and regulatory question.
• Advise on endpoint selection, adaptive and interim designs, and multiplicity strategy.
• Oversee CRO biostatistics and programming: SDTM/ADaM specifications, define.xml, validation approach, TLF review and delivery timelines.
• Contribute to statistical and programming vendor selection and scope; review change orders for statistical work.
• Support data monitoring committees and interim analyses, including firewalls and unblinding controls.
• Interpret and present results; co-author CSRs and statistical sections of regulatory documents, briefing books and responses to agency questions.
• Design analysis approaches for Phase 3b/4, registry, real-world and chart review studies, including observational methods (e.g. propensity score methods, handling of missing data and bias).
• Support publications, congress abstracts, post-hoc and exploratory analyses with appropriate statistical rigor.
• Set portfolio statistical standards and SAP templates; partner with the Clinical Data Manager on data standards and lock readiness.
• Provide statistical input to development plans, evidence-generation plans and business development due diligence.
• Other duties as assigned.

Conhecimentos

Communication

Statistical leadership

Project management

Formação académica

PhD in biostatistics or statistics

MS with 10+ years experience

Ferramentas

SAS

R

CDISC SDTM/ADaM

Descrição da oferta de emprego

Precigen, Inc. is seeking a Senior Biostatistician to lead sponsor-driven statistics across Clinical Development and Medical Affairs, partnering with Clinical Development, Medical Affairs and Regulatory to ensure robust study design and analysis.

The role requires directing CRO biostatistics, overseeing SDTM/ADaM workflows, and guiding endpoint selection, adaptive designs, and regulatory reporting with strong communication to stakeholders.