Director of Statistical Programming — Hybrid Biotech

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

Job summary

Director, Statistical Programming - Clinical at NWRPros in Kirkland, WA. Hybrid role leading strategic and operational programming across clinical development programs, ensuring timely, high-quality deliverables for regulatory submissions.

You will oversee junior staff and CRO partners, drive SDTM/ADaM programming in SAS, and shape SOPs while collaborating with biostatistics and data management to support Phase 1b/2 trials and potential later-stage programs.

Qualifications

• Bachelor’s degree or higher in a relevant field.
• 15+ years as a statistical programmer in biotech/pharma.
• Expert 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 related deliverables.
• 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 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 programming groups to ensure timelines and quality.
• Develop SOPs for statistical programming function.

Skills

Biotech/pharma experience

CDISC SDTM/ADaM

Regulatory submissions

Education

Bachelor’s degree or higher

Tools

SAS

Pinnacle 21

Job description

Director, Statistical Programming - Clinical at NWRPros in Kirkland, WA. Hybrid role leading strategic and operational programming across clinical development programs, ensuring timely, high-quality deliverables for regulatory submissions.

You will oversee junior staff and CRO partners, drive SDTM/ADaM programming in SAS, and shape SOPs while collaborating with biostatistics and data management to support Phase 1b/2 trials and potential later-stage programs.