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Kailera Therapeutics · 21 hours ago

Director, Biostatistics

Greater Boston

Full-time

Hybrid

Director/Executive

$175K/yr - $230K/yr

8+ years exp

Kailera Therapeutics is committed to developing therapies that empower individuals to enhance their health. The Director of Biostatistics will lead statistical support for clinical studies, ensuring alignment with clinical development objectives and regulatory expectations while overseeing the accuracy and integrity of statistical analyses.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Lead statistical efforts for early-to-late phase clinical studies, key regulatory, and submission activities

Provide statistical leadership in the development and execution of clinical development strategies by collaborating with cross-functional teams

Lead the development and the adoption of innovative statistical approaches (e.g., adaptive, seamless, Bayesian designs) to enhance trial efficiency, optimize resource utilization, and increase the probability of success

Ensure the accuracy, integrity, and consistency of statistical analyses across all clinical development programs, from Phase I through regulatory submissions and post-approval activities

Oversee CRO activities, ensuring quality deliverables, adherence to timelines, and efficient resource utilization

Qualification

BiostatisticsStatistical software SASStatistical software RRegulatory submissionsInnovative statistical methodologiesLeadership experienceProblem-solving skillsStrategic thinkingCommunication skillsInterpersonal skills

Required

Advanced degree (PhD/MS) in Biostatistics or Statistics

PhD: Minimum of 8+ years of relevant experience

MS: Minimum of 10+ years of relevant experience

Successful experience in regulatory submissions, including NDAs, BLAs, and other filings

Strong leadership in statistical activities supporting clinical development programs

Participated in implementing innovative statistical methodologies to enhance clinical trial efficiency and effectiveness

Hands-on expertise with statistical software (e.g., SAS, R) and familiarity with CDISC standards

Strong problem-solving and strategic thinking skills, with the ability to translate complex statistical concepts into actionable insights for diverse stakeholders

Excellent communication and interpersonal skills, with the ability to influence decision-making and foster collaboration across functions

Extensive leadership experience in overseeing CRO activities

Benefits

Comprehensive health coverage

Flexible time off

Paid holidays

Year-end shutdown

Monthly wellness stipend

Generous 401(k) match

Tuition reimbursement

Commuter benefits

Disability and life insurance

Annual bonus opportunities

Equity grants

Company

Kailera Therapeutics

Kailera Therapeutics develops next-generation injectable and oral therapies for chronic weight management.

Founded in 2024

Waltham, Massachusetts, USA

51-200 employees

https://www.kailera.com

Funding

Current Stage

Growth Stage

Total Funding

$1B

Key Investors

Bain Capital Private Equity

2025-10-14Series B· $600M

2024-10-01Series A· $400M

Leadership Team

Ronald Renaud

President & CEO

Paul Burgess

Chief Operating Officer and Chief Business Officer

Recent News

Boston Globe

Mass. startups raised more VC money last year, but those in other states did much better

2026-01-16

GlobeNewswire

Kailera Therapeutics Announces First Participants Randomized in KaiNETIC Global Phase 3 Clinical Program of GLP-1/GIP Receptor Dual Agonist Ribupatide (KAI-9531)

2026-01-13

GlobeNewswire

Kailera Therapeutics Appoints Doug Pagán as Chief Financial Officer

2026-01-05

Company data provided by crunchbase