Principal Biostatistician & Lead, Clinical Development

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

Resumo da oferta

Precigen is seeking a Principal Biostatistician to serve as the sponsor's statistical lead for all company-sponsored studies across Clinical Development and Medical Affairs. You will own the statistical science from study design through interpretation and supervise CRO statistics and programming teams to sponsor standards.

You will partner with Clinical Development, Medical Affairs and Regulatory, guiding complex analyses for Phase 3b/4, real-world data and registry studies while ensuring

Qualificações

• PhD in biostatistics or statistics with 10+ years or MS with 14+ 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.

Conhecimentos

Biostatistics expertise

Clinical development

Statistical programming

SAS

R

Formação académica

PhD in Biostatistics

MS in Biostatistics

Ferramentas

CDISC SDTM/ADaM

Descrição da oferta de emprego

Precigen is seeking a Principal Biostatistician to serve as the sponsor's statistical lead for all company-sponsored studies across Clinical Development and Medical Affairs. You will own the statistical science from study design through interpretation and supervise CRO statistics and programming teams to sponsor standards.

You will partner with Clinical Development, Medical Affairs and Regulatory, guiding complex analyses for Phase 3b/4, real-world data and registry studies while ensuring