Director, Statistical Programming & Regulatory Submissions

Eupraxia Pharmaceuticals Inc.; Seattle (WA); Hybrid; USD 160,000 - 190,000; Full time

Job summary

Eupraxia Pharmaceuticals Inc. in Kirkland, WA, is seeking an Associate Director of Statistical Programming to provide strategic leadership for programming across clinical development programs.

The role emphasizes collaboration with cross-functional teams to ensure timely, compliant submissions and high-quality analyses. Based in a hybrid Kirkland environment, you will oversee CROs and internal staff, develop the SP environment, and drive standards for regulatory deliverables and publications,

Qualifications

• Bachelor’s degree or higher in a relevant field.
• 15+ years biotech/pharma experience as a statistical programmer.
• Expert level knowledge of CDISC SDTM/ADaM and SAS.
• Experience preparing study data and output for regulatory submissions.
• Demonstrated experience supporting pivotal and registrational clinical trials.
• Strong CRO and vendor oversight experience.
• Track record of delivering high-quality programming deliverables.
• Strong experience with Pinnacle 21.

Responsibilities

• Lead statistical programming activities across one or more clinical development programs.
• Program and validate deliverables for interim and final analyses, publications, abstracts, CSRs, and regulatory submissions.
• Collaborate with study biostatisticians to develop and implement TLF programming for statistical analysis plans.
• Assist data management in the development and programming of non-system edit checks for clinical trial data.
• Develop and maintain the statistical programming environment for biometrics.
• Provide hands-on oversight of CROs and external statistical programming groups to ensure quality standards and timelines.
• Develop SOPs for statistical programming function.

Skills

CDISC knowledge

SAS

Regulatory submissions

Vendor oversight

Team leadership

Statistical programming

R (plus)

Education

Bachelor’s degree or higher

Tools

SAS

Pinnacle 21

R

Job description

Eupraxia Pharmaceuticals Inc. in Kirkland, WA, is seeking an Associate Director of Statistical Programming to provide strategic leadership for programming across clinical development programs.

The role emphasizes collaboration with cross-functional teams to ensure timely, compliant submissions and high-quality analyses. Based in a hybrid Kirkland environment, you will oversee CROs and internal staff, develop the SP environment, and drive standards for regulatory deliverables and publications,