Hybrid Associate Director, Statistical Programming

NWRPros; Kirkland (WA); Hybrid; USD 170,000 - 220,000; Full time

Job summary

NWRPros in Kirkland, WA seeks an Associate Director of Statistical Programming to lead programming across clinical programs and oversee regulatory submissions. The role emphasizes strategic leadership, cross-functional collaboration, and ensuring high-quality deliverables.

The candidate will manage CROs and external groups, develop SOPs, and drive the programming environment for biometrics, with extensive CDISC and SAS expertise required.

Qualifications

• Bachelor’s degree or higher.
• 15+ years of biotech/pharma experience as a statistical programmer.
• Expert level knowledge of CDISC standards (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 related 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 are met for programming related deliverables.
• Develop SOPs for statistical programming function.

Skills

CDISC SDTM/ADaM

SAS

Pinnacle 21

CRO/vendor oversight

Regulatory submissions

Leadership

Education

Bachelor’s degree or higher

Tools

R

Job description

NWRPros in Kirkland, WA seeks an Associate Director of Statistical Programming to lead programming across clinical programs and oversee regulatory submissions. The role emphasizes strategic leadership, cross-functional collaboration, and ensuring high-quality deliverables.

The candidate will manage CROs and external groups, develop SOPs, and drive the programming environment for biometrics, with extensive CDISC and SAS expertise required.