Senior Manager​/Associate Director Statistical Programming - Bilingual Chinese

Sr. Manager / Associate Director, Statistical Programming

We are seeking a Senior Manager or Associate Director of Statistical Programming to lead statistical programming activities across complex clinical development programs. This role oversees high‑quality, on‑time delivery of datasets, TLGs, and regulatory submissions, manages and develops programming teams and vendors, and serves as the programming lead on key studies. The position partners closely with biostatistics and cross‑functional teams to support study design, regulatory readiness, and continuous improvement of programming standards and processes.

This is a bilingual role in Chinese and English and can be based in Sugar Land, TX, Princeton, NJ, or Redmond, WA.

• Responsible for statistical programming activities within a therapeutic project or equivalent.
• Lead, manage, develop and support the statistical programming team.
• Manage critical deadlines, demonstrate problem‑solving ability, and ensure quality programmatic deliverables are completed on time.
• Serve as project leader on studies or tasks of greater complexity.
• Attend multi‑disciplinary team meetings, representing the statistical programming function.
• Create or review and approve programming plans at study and project level.
• Provide input on key study‑related documents produced by other functions (e.g., CRFs, Data Management Plan, SAPs, etc.).
• Provide programming leadership for preparation of datasets and TLGs (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies.
• Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies.
• Assist statisticians by suggesting algorithms to address novel analysis requests.
• Develop software validation procedures and test plans, as necessary.
• Create and document archives of software, outputs, and analysis files.
• Contribute to the creation and maintenance of department SOPs related to clinical data analysis.
• Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.
• Oversee work of internal contract programmers and external vendors.
• Provide time and resource estimates for project planning.

• BSc or MS in a numerate discipline (preferably Statistics, Computer Science, or Mathematics).
• Preferably at least 10 years of experience in biostatistics or statistical programming in the pharmaceutical/biotechnology industry in clinical development.
• At least 5 years of experience as a statistical programming team leader or manager.
• Fluency in English and Chinese.
• Strong knowledge of relevant regulatory (FDA, NMPA, EMA, PMDA, etc.) and data submission guidelines.
• Strong understanding of drug development, including interfaces and interdependencies with other functions.
• Consistent experience as a lead statistical programmer on several concurrent NDA projects.
• Strong knowledge of the relevant therapeutic areas and CDISC standards.
• Self‑directed, technically strong, and a recognized leader who maintains a strategic perspective on statistical programming processes and vendor management.
• Strong project management skills.

The expected base salary range for this position is $150,000 – $200,000 annually. Actual compensation will be based on a variety of factors, including but not limited to the candidate’s qualifications, experience, and skills.

We offer a comprehensive benefits package including 100% paid employee premiums for medical/dental/vision, STD, LTD, a 401(k) plan with a 50% company match up to 3% and a vesting schedule of 5 years, 15 PTO days per year, sick leave, 11 paid holidays, and additional perks.

We are an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.