Associate Director, Statistical Programming

Kailera Therapeutics

. Lead statistical programming efforts for clinical studies .

Posted 10/7/2026full-timeWaltham • Massachusetts • United StatesSenior💰 $159,000 - $195,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading statistical programming for clinical studies, with a strong focus on SAS programming, CDISC standards, and regulatory submissions. Proven ability to manage CRO activities and ensure high-quality deliverables while collaborating effectively with cross-functional teams.

Highest-signal resume keywords

SAS ProgrammingCDISC StandardsRegulatory SubmissionsCRO ManagementBiostatistics

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Applicant Tracking System Keywords

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Hard Skills

Statistical ProgrammingProgramming SpecificationsAd-Hoc AnalysesIndependent ValidationQuality ChecksClinical DevelopmentLate-Phase Clinical TrialsISS/ISE ExperienceDataset OversightStatistical Deliverables

Soft Skills

CollaborationProject ManagementPrioritization

Certifications & Qualifications

E-Verify Employment Eligibility

Industry Keywords

Clinical StudiesFDAEMAICH/GCP GuidelinesNDABLACRO ActivitiesTFLsSDTMADaM

About the role

Key responsibilities & impact

Lead statistical programming efforts for clinical studies
Develop and review programming specifications for clarity, integrity, and compliance with internal and external standards
Lead ad-hoc and post-hoc analyses supporting clinical questions, publications, and internal decision-making
Oversee and coordinate CRO activities involving CDISC standards, SDTM, ADaM datasets, and TFLs
Ensure high-quality CRO deliverables
Conduct independent validation and quality checks of CRO statistical programming deliverables
Collaborate with statisticians and cross-functional study teams to deliver timely and accurate results
Manage multiple projects and prioritize tasks to meet deadlines

Requirements

What you’ll need

Hands-on programming experience in clinical development, preferably in a leadership role
Strong preference for late-phase clinical trial support
Experience in regulatory submissions, including NDAs, BLAs, and other filings
Experience in ISS/ISE highly desirable
Expertise in SAS programming
Comprehensive knowledge of CDISC standards
Familiarity with ICH/GCP guidelines and global regulatory submission requirements, including FDA and EMA
Extensive experience overseeing CROs, including independent validation of datasets and statistical deliverables
Advanced degree (MS/PhD) in Biostatistics, Statistics, or a related field
MS: minimum of 8+ years of relevant experience
PhD: minimum of 6+ years of relevant experience
E-Verify employment eligibility for new hires

Benefits

Comp & perks

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