Senior Biostatistician

Precigen, Inc; Germantown (MD); On-site; USD 170,000 - 185,000; Full time

Job summary

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.

Qualifications

• 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.

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.

Skills

Communication

Statistical leadership

Project management

Education

PhD in biostatistics or statistics

MS with 10+ years experience

Tools

SAS

R

CDISC SDTM/ADaM

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

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

Salary Range: $170,000.00 To $185,000.00 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 AdenoVerse® 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.