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Kailera Therapeutics · 13 hours ago

Associate Director, Statistical Programming

Waltham, Massachusetts

Full-time

Hybrid

Lead/Staff, Director/Executive

$160K/yr - $200K/yr

5+ years exp

Kailera is committed to developing therapies that empower individuals to enhance their health. They are seeking an Associate Director, Statistical Programming to lead statistical programming activities for clinical trials and regulatory submissions.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Lead statistical programming efforts for clinical studies, including the development and review of programming specifications to ensure clarity, integrity, and compliance with internal and external standards

Oversee and coordinate activities with Contract Research Organizations (CROs), focusing on the implementation of CDISC standards, creation of SDTM, ADaM datasets, and TFLs, and ensuring high-quality deliverables

Conduct independent validation and quality checks of statistical programming deliverables from CROs

Collaborate closely with statisticians and cross-functional study teams to deliver results in a timely and accurate manner

Manage multiple projects simultaneously, ensuring tasks are prioritized effectively to meet deadlines

Qualification

SAS programmingCDISC standardsRegulatory submissionsClinical developmentStatistical programmingICH/GCPCROsLeadership experienceCollaboration skillsProject management

Required

Minimum of 7+ years of relevant experience with MS, 5+ years of relevant experience with PhD

Proven hands-on experience in programming for clinical development, preferably in a leadership role, with a strong preference for late-phase clinical trial support

Experience in regulatory submissions, including NDAs, BLAs, and other filings, with experience in ISS/ISE highly desirable

Expertise in SAS programming and comprehensive knowledge of CDISC standards

Familiarity with ICH/GCP guidelines and global regulatory submission requirements (e.g., FDA, EMA)

Extensive experience overseeing CROs, including independent validation of datasets and statistical deliverables

Advanced degree (MS/PhD) in Biostatistics, Statistics, or a related field