Associate Director, Statistical Programming (Hybrid)

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

Job summary

NWRPros in Kirkland, WA seeks an Assoc Director of Statistical Programming to lead programming across clinical development programs in a hybrid Kirkland, WA setting.

Responsibilities include ensuring timely, high-quality outputs for INDs, IBs, NDA/BLAs, CSRs, and publications, and overseeing CROs with cross-functional collaboration across biostatistics and data management. A strong registry of CDISC SDTM/ADaM and SAS is required.

Qualifications

• Bachelor’s degree or higher in a relevant field.
• 15+ years biotech/pharma experience as a statistical programmer.
• Expert level knowledge of CDISC standards (SDTM, ADaM) and SAS.

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 standards (SDTM/ADaM)

SAS

Biotech/pharma experience

Education

Bachelor’s degree or higher

Tools

Pinnacle 21

Job description

NWRPros in Kirkland, WA seeks an Assoc Director of Statistical Programming to lead programming across clinical development programs in a hybrid Kirkland, WA setting.

Responsibilities include ensuring timely, high-quality outputs for INDs, IBs, NDA/BLAs, CSRs, and publications, and overseeing CROs with cross-functional collaboration across biostatistics and data management. A strong registry of CDISC SDTM/ADaM and SAS is required.