Principal Biostatistician

Precigen, Inc•Germantown, MD

1d•$190,000 - $215,000

About The Position

The Principal Biostatistician is the sponsor’s statistical lead for company-sponsored studies and evidence-generation activities across Clinical Development and Medical Affairs. Statistical programming and analysis are outsourced, while this role owns the statistical science from study design through interpretation and ensures CRO statistics and programming teams meet sponsor standards. The role partners scientifically with Clinical Development, Medical Affairs, and Regulatory. The position authors or approves statistical content for protocols, amendments, statistical analysis plans, and regulatory and scientific communications. It provides statistical guidance on study design, endpoints, estimands, sample size, randomization, interim and adaptive designs, multiplicity, and analysis methods. The role also oversees CRO statistical and programming work, supports data monitoring committees and interim analyses, contributes to vendor selection and scope, and establishes portfolio statistical standards. The Principal Biostatistician interprets and presents study results; contributes to clinical study reports, regulatory documents, agency responses, publications, abstracts, and exploratory analyses; and designs analyses for Phase 3b/4, registry, real-world, and chart review studies. The role also contributes statistical input to development and evidence-generation plans and business development due diligence.

Requirements

PhD in biostatistics or statistics with 10 or more years of experience, or MS with 14 or more years of experience.
Experience across clinical development phases.
Experience overseeing CRO statistics and programming.
Working knowledge of SAS and/or R and CDISC SDTM/ADaM.
Knowledge of ICH E9 and E9(R1), and FDA and EMA statistical guidance.
Clear communication skills with non-statisticians, including executives and regulators.
Self-organized, highly motivated, and attentive to detail.
Excellent interpersonal, verbal, and written communication skills.
Ability to understand and execute the company’s mission and values.
High ethical standards and trustworthiness.
Open mindset when approaching challenges and conflict.
Ability to think and adapt in a rapidly changing environment and to changing demands.
Strong time-management and organizational skills.
Ability to manage multiple projects in a fast-paced environment.

Nice To Haves

Registrational study or submission experience is strongly preferred.
Real-world evidence or observational methods experience is valued.

Responsibilities

Author or approve statistical sections of protocols and amendments, including objectives, estimands, endpoints, sample size, and randomization.
Author or approve statistical analysis plans and table, listing, and figure (TLF) shells, ensuring analyses address the scientific and regulatory questions.
Advise on endpoint selection, adaptive and interim designs, and multiplicity strategies.
Oversee CRO biostatistics and programming, including SDTM/ADaM specifications, define.xml, validation approaches, TLF review, and delivery timelines.
Contribute to statistical and programming vendor selection and scope, and review change orders for statistical work.
Support data monitoring committees and interim analyses, including firewalls and unblinding controls.
Interpret and present results; co-author clinical study reports 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 such as propensity score methods and approaches to missing data and bias.
Support publications, congress abstracts, post-hoc analyses, 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.
Perform other duties as assigned.