Biostatistics Associate Director - Clinical Trial Design

Harmony Biosciences; Harmonville (PA); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Medical Vision Dental

Paid time off

401(k) plan

Parental leave

ESPP

Wellness programs

Professional development

Great Place to Work

Job summary

Harmony Biosciences is seeking an Associate Director of Biostatistics to join the Clinical Biostatistics team in Plymouth Meeting, PA. You will ensure statistical soundness of input and deliverables across late-stage studies and collaborate with regulatory authorities.

You will partner with Clinical teams on trial design, apply advanced methods, contribute to standards, and lead complex projects while keeping current with regulatory guidance and new statistical methodologies.

Qualifications

• Master's Degree in Biostatistics required; PhD preferred.
• 5+ years applying statistical methods in biomedical research.
• 3+ years in pharmaceutical or CRO environments.
• 3+ years of ADaM experience.
• Experience with late-stage development is strongly preferred.
• Strong SAS programming skills; R knowledge is a plus.

Responsibilities

• Support statistical elements of study design, analysis, and decision-making.
• Develop and evaluate infrastructure to facilitate trials.
• Select and implement statistical methodologies and processes.
• Review project documents for statistical presentation and compliance.
• Contribute to standards for variables, data structures and presentation.
• Prepare statistical aspects for meetings with regulators and KOLs.
• Interact with clinical investigators to determine protocol design.
• Evaluate databases and analysis tools for optimal solutions.
• Stay updated with new methods and regulatory guidance.

Skills

Statistical methods

SAS

R programming

Biostatistics

Regulatory knowledge

Education

Master's Degree in Biostatistics

PhD preferred

Job description

Harmony Biosciences is seeking an Associate Director of Biostatistics to join the Clinical Biostatistics team in Plymouth Meeting, PA. You will ensure statistical soundness of input and deliverables across late-stage studies and collaborate with regulatory authorities.

You will partner with Clinical teams on trial design, apply advanced methods, contribute to standards, and lead complex projects while keeping current with regulatory guidance and new statistical methodologies.