SystImmune Inc.
Sr. Manager/Associate Director Statistical Programming
SystImmune Inc., Redmond, Washington, United States, 98052
SystImmune is a leading and well‑funded clinical‑stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi‑specific, multi‑specific antibodies, and antibody‑drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications, alongside ongoing clinical trials and a robust preclinical pipeline of potential cancer therapeutics in the discover and IND‑enabling stages, representing cutting‑edge biologics development.
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. It can be based in
Sugar Land, TX, Princeton, NJ, or Redmond, WA.
This is a bilingual role in Chinese and English.
Responsibilities
Responsible for statistical programming activities within a therapeutic project or equivalent
Lead, manage, develop and support statistical programming team
Manage critical deadlines, demonstrate problem‑solving ability, and ensure quality statistical programming deliverables will be completed within designated timeframe
Serve as project leader on studies or tasks of greater complexity
Attend multidisciplinary 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
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
Compensation and Benefits 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 a candidate’s qualifications, experience, and skills. While most offers typically fall within the low to mid‑point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.
We offer a comprehensive benefits package including: 100% paid employee premiums for medical, dental, and vision; STD; LTD; a 401(k) plan with a 50% company match up to 3% and a vesting schedule of only 5 years; 15 PTO days per year; sick leave; plus 11 paid holidays and more.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
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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. It can be based in
Sugar Land, TX, Princeton, NJ, or Redmond, WA.
This is a bilingual role in Chinese and English.
Responsibilities
Responsible for statistical programming activities within a therapeutic project or equivalent
Lead, manage, develop and support statistical programming team
Manage critical deadlines, demonstrate problem‑solving ability, and ensure quality statistical programming deliverables will be completed within designated timeframe
Serve as project leader on studies or tasks of greater complexity
Attend multidisciplinary 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
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
Compensation and Benefits 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 a candidate’s qualifications, experience, and skills. While most offers typically fall within the low to mid‑point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.
We offer a comprehensive benefits package including: 100% paid employee premiums for medical, dental, and vision; STD; LTD; a 401(k) plan with a 50% company match up to 3% and a vesting schedule of only 5 years; 15 PTO days per year; sick leave; plus 11 paid holidays and more.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
#J-18808-Ljbffr