Senior Manager, Statistical Programming — Bilingual EN/CN

Systimmune; Bothell (WA); On-site; USD 150,000 - 200,000; Full time

Benefits offered by this job

Medical premiums

Dental premiums

Vision premiums

401(k) match

Job summary

SystImmune, a clinical-stage biopharmaceutical company, is seeking a Senior Manager or Associate Director of Statistical Programming to lead programming across complex clinical development programs. The role partners with biostatistics and cross-functional teams to support study design, regulatory readiness, and continuous process improvement.

The position can be based in Princeton, NJ or Bothell, WA and requires fluency in English and Chinese.

Qualifications

• BSc or MS in a numerate discipline.
• At least 10 years in biostatistics or statistical programming in Pharma/Biotech.
• At least 5 years leading a statistical programming team or function.
• Fluency in English and Chinese.
• Strong knowledge of regulatory guidelines (FDA, EMA, etc.).

Responsibilities

• Lead statistical programming activities within therapeutic projects.
• Manage and develop statistical programming teams and vendors.
• Ensure on-time, high-quality deliverables (datasets, TLGs, regulatory submissions).
• Provide programming leadership for NDA/BLA data packages to regulatory agencies.
• Review study documents and contribute to SAPs, DMPs, and CRFs.
• Oversee internal and external programmers and provide resource estimates.
• Develop and validate software for tables, listings and graphs.

Skills

Leadership

Statistical programming

Project management

Regulatory submissions

Cross-functional collaboration

Bilingual English/Chinese

Education

BSc or MS in Statistics/CS/Mathematics

Job description

SystImmune, a clinical-stage biopharmaceutical company, is seeking a Senior Manager or Associate Director of Statistical Programming to lead programming across complex clinical development programs. The role partners with biostatistics and cross-functional teams to support study design, regulatory readiness, and continuous process improvement.

The position can be based in Princeton, NJ or Bothell, WA and requires fluency in English and Chinese.