SystImmune ยท 1 day ago
Senior Manager/Associate Director Statistical Programming - Bilingual Chinese
Redmond, WA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$150K/yr - $200K/yr
10+ years expSystImmune is a leading and well-funded clinical-stage biopharmaceutical company specializing in developing innovative cancer treatments. They are seeking a Senior Manager or Associate Director of Statistical Programming to lead statistical programming activities across complex clinical development programs, ensuring high-quality deliverables and managing programming teams and vendors.
BiopharmaBiotechnologyProfessional Services
Responsibilities
Responsible for statistical programming activities within a therapeutic project or equivalent
Lead, manage, develop and support statistical programming team
Manage critical deadlines, demonstrate ability to problem solving, and ensure quality statistical programming deliverables will be completed within designated timeframe
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
Qualification
Required
BSc or MS (in a numerate discipline preferably in Statistics, Computer Science, or Mathematics)
Preferably at least 10 years of experience in biostatistics or statistical programming activities 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 knowledge of 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 maintaining a strategic prospective with regard to statistical programming processes, management of statistical programmers and customer management
Strong project management skills
Benefits
100% paid employee premiums for medical/dental/vision
STD
LTD
401(k) plan with a 50% company match of up to 3%
Vesting schedule of only 5 years
15 PTO days per year
Sick leave
11 paid holidays
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Company
SystImmune
SystImmune is a biotechnology company.
51-200 employees
H1B Sponsorship
SystImmune has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (14)
2023 (1)
2022 (2)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Martin S. Olivo, MD, MSc,
Chief Medical Officer
Recent News
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