Lead Statistical Programming & Submissions (CDISC)

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

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.