Associate Director, Statistical Programming

We are seeking an experienced programmer to join us as Associate Director, Statistical Programming. This is a critical role responsible for leading statistical programming activities on the assigned disease area(s). This role will support clinical trials, regulatory submissions, and other key initiatives.

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; Lead the execution of ad-hoc and post-hoc analyses to support emerging clinical questions, publications, and internal decision-making; 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

Requirements

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; MS: Minimum of 8+ years of relevant experience; PhD: Minimum of 6+ years of relevant experience

Nice to have

Background in cardiometabolic diseases or related therapeutic areas

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