Senior Director, Statistical Programming — Hybrid

NWRPros; Kirkland (WA); Hybrid; USD 150,000 - 230,000; Full time

Job summary

NWRPros is seeking an Associate Director of Statistical Programming in Kirkland, WA, offering a hybrid work environment. The role leads programming activities across clinical programs, ensuring timely, high-quality outputs for regulatory submissions and publications.

The candidate will partner with biostatistics to implement SAPs, oversee CROs, and develop programming SOPs, with potential supervisory responsibilities for junior programmers.

Qualifications

• Experience with presenting study data for regulatory submissions.
• Track record of delivering high-quality programming deliverables.
• Strong CRO and vendor oversight experience.
• Expert level knowledge of CDISC standards (SDTM/ADaM) and SAS.
• Knowledge of R is a plus.

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 biostatisticians to develop and implement TLF programming for SAPs.
• Assist data management in developing non-system edit checks for trial data.
• Develop and maintain the statistical programming environment for biometrics.
• Oversee CROs and external programming groups to meet standards and timelines.
• Develop SOPs for statistical programming functions.

Skills

CDISC standards (SDTM/ADaM)

SAS

Vendor oversight

Pinnacle 21

R knowledge

Education

Bachelor’s degree or higher

Tools

SAS

Pinnacle 21

Job description

NWRPros is seeking an Associate Director of Statistical Programming in Kirkland, WA, offering a hybrid work environment. The role leads programming activities across clinical programs, ensuring timely, high-quality outputs for regulatory submissions and publications.

The candidate will partner with biostatistics to implement SAPs, oversee CROs, and develop programming SOPs, with potential supervisory responsibilities for junior programmers.