Director of Statistical Programming & Regulatory Submissions

Run my Accounts AG; Seattle (WA); On-site; USD 160,000 - 190,000; Full time

Job summary

Eupraxia in Kirkland, WA, is seeking an Associate Director of Statistical Programming to lead programming activities across clinical programs and ensure timely, high-quality deliverables for regulatory submissions. You will work cross-functionally with biostatisticians and data management in a hybrid environment.

The role requires deep CDISC/SAS expertise, 15+ years in biotech/pharma programming, and experience overseeing CROs, with a focus on delivering pivotal trial data for IND/ NDA

Qualifications

• Bachelor’s degree or higher in a scientific field.
• 15+ years biotech/pharma experience as a statistical programmer.
• Expert knowledge of CDISC SDTM/ADaM and SAS.
• Experience preparing study data and output for regulatory submissions.
• Strong CRO and vendor oversight experience.
• Track record delivering high-quality programming deliverables.
• Familiarity 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, CSR, and regulatory submissions.
• Collaborate with study biostatisticians to develop and implement TLF programming for SAPs.
• Assist data management in the development and programming of non-system edit checks for 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 and timelines.
• Develop SOPs for statistical programming function.

Skills

Statistical programming

Leadership

Regulatory collaboration

Education

Bachelor’s degree or higher

15+ years biotech/pharma statistical programming

Tools

SAS

CDISC SDTM/ADaM

Pinnacle 21

Vendor CRO oversight

Job description

Eupraxia in Kirkland, WA, is seeking an Associate Director of Statistical Programming to lead programming activities across clinical programs and ensure timely, high-quality deliverables for regulatory submissions. You will work cross-functionally with biostatisticians and data management in a hybrid environment.

The role requires deep CDISC/SAS expertise, 15+ years in biotech/pharma programming, and experience overseeing CROs, with a focus on delivering pivotal trial data for IND/ NDA