Associate Director, Statistical Programming

Kailera Therapeutics, Inc.; Waltham (MA); On-site; USD 159,000 - 195,000; Full time

Benefits offered by this job

Comprehensive health coverage

Flexible time off

Paid holidays

Monthly wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability and life insurance

Annual bonus opportunities

Equity grants

Job summary

A biotech firm in Waltham, Massachusetts, is looking for an experienced Associate Director of Statistical Programming. This role involves leading statistical programming for clinical trials and regulatory submissions while managing relationships with CROs. Candidates should have a strong background in SAS programming and substantial experience in clinical development, particularly in late-phase trials. An advanced degree in a relevant field is required, along with a passion for advancing novel therapies for obesity and related conditions.

Qualifications

• Minimum 8 years of experience for MS or 6 years for PhD in programming for clinical trials.
• Expertise in SAS programming with knowledge of CDISC standards.
• Experience in regulatory submissions including NDAs and BLAs.

Responsibilities

• Lead statistical programming efforts for clinical studies.
• Oversee and coordinate activities with CROs for high-quality deliverables.
• Conduct validation and quality checks of deliverables from CROs.

Skills

SAS programming

Clinical development

CDISC standards

Regulatory submissions

Project management

Education

Advanced degree in Biostatistics, Statistics, or related field

Job description

Associate Director, Statistical Programming

Waltham, Massachusetts

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

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)

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

Required Qualifications:

• 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

Preferred Qualifications:

• Background in cardiometabolic diseases or related therapeutic areas is preferred

Education:

• 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

Salary Range

$159,000 - $195,000 USD

For Full Time Roles: 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.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:

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.