Associate Director, Statistical Programming

What You’ll Do:

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.

Required location:
Waltham, MA (hub-based, onsite 3-4 days per week).

• 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.

• 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.

• Background in cardiometabolic diseases or related therapeutic areas.

• 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.

$159,000 — $195,000 USD

This range represents the company’s good‑faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year‑end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well‑being and future matter to us.

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy‑related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.