Senior Biostatistician

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Regulatory and Clinical Full-time Regular Germantown, MD, US

2 days ago Requisition

Salary Range: $ To $ Annually

Precigen(Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need.

Precigenis dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies utilizing the company’s Adeno Verse® and UltraCAR-T® therapeutic platforms across its core focus areas of immuno-oncology, autoimmune disorders, and infectious diseases.

POSITION SUMMARY:

The Senior Biostatistician is the sponsor's statistical lead for all company-sponsored studies and evidence-generation activities across Clinical Development and Medical Affairs. Statistical programming and analysis are outsourced; this role owns the statistical science, from study design through interpretation, and holds CRO statistics and programming teams to sponsor standards. The role is a scientific partner to Clinical Development, Medical Affairs and Regulatory.

DUTIES AND RESPONSIBILITIES:

• 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.

EDUCATION AND EXPERIENCE:

• 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.

DESIRED KEY

COMPETENCIES:

• Self-organizer, highly motivated, and keen attention to detail.
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• Ability to understand and execute the company’s mission and values.
• Maintain a high degree of ethical standard and trustworthiness.
• Exhibits an open mindset when approaching challenges and conflict.
• Ability to think and adapt to a rapidly changing environment and demands.
• Strong time management and organizational skills.
• Ability to manage multiple projects in a fast-paced environment.