Sr. Manager/Associate Director Statistical Programming
About The Position
SystImmune is 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, and can be based in Sugar Land, TX, Princeton, NJ, or Redmond, WA. This is a bilingual role in Chinese and English.
Requirements
- 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
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.
Benefits
- SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
11-50 employees
