Senior Biostatistician

Precigen, Inc•Germantown, MD

21h•$170,000 - $185,000

About The Position

The Senior 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, and this role owns statistical science from study design through interpretation while ensuring CRO statistics and programming teams meet sponsor standards. The role partners scientifically with Clinical Development, Medical Affairs, and Regulatory. The position develops or approves statistical components of protocols, statistical analysis plans, and regulatory and clinical documents; advises on study design and analysis; and oversees CRO biostatistics and programming activities. It also supports evidence generation beyond traditional clinical trials, including Phase 3b/4, registry, real-world, and chart review studies, and contributes to portfolio standards, development planning, publications, and business development due diligence.

Requirements

PhD in biostatistics or statistics with at least 6 years of industry experience, or an MS with at least 10 years of industry 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 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 adapt to a rapidly changing environment and 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.
Experience with real-world evidence or observational methods 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 TLF shells, ensuring analyses address the scientific and regulatory questions.
Advise on endpoint selection, adaptive and interim designs, and multiplicity strategy.
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.