Associate Director, Statistical Programming — Clinical Trials Lead

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

Benefits offered by this job

Comprehensive health coverage

Flexible time off

401(k) match

Tuition reimbursement

Monthly wellness stipend

Annual bonus opportunities

Equity grants

Job summary

Kailera Therapeutics in Waltham, MA, is looking for an Associate Director, Statistical Programming to lead programming activities crucial for clinical trials and regulatory submissions. This role is ideal for candidates with significant experience in SAS programming and a proven history in managing late-phase clinical trials.

The ideal candidate will have an advanced degree in Biostatistics or Statistics and extensive experience overseeing CROs. A passion for transforming health through innovative therapies is essential.

Qualifications

• 8+ years of relevant experience with a MS or 6+ years with a PhD in Biostatistics or related field.
• Hands-on experience in programming for clinical development.
• Expertise in regulatory submissions and late-phase clinical trials.

Responsibilities

• Lead statistical programming for clinical studies, ensuring compliance and high-quality deliverables.
• Oversee ad-hoc analyses supporting clinical decisions and publications.
• Coordinate with CROs to implement CDISC standards.

Skills

SAS programming

CDISC standards

Regulatory submissions

Project management

Statistical programming

Education

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

Job description

Kailera Therapeutics in Waltham, MA, is looking for an Associate Director, Statistical Programming to lead programming activities crucial for clinical trials and regulatory submissions. This role is ideal for candidates with significant experience in SAS programming and a proven history in managing late-phase clinical trials.

The ideal candidate will have an advanced degree in Biostatistics or Statistics and extensive experience overseeing CROs. A passion for transforming health through innovative therapies is essential.