About this role
Thanks for visiting our Career Page. Please review our open positions and apply to the positions that match your qualifications.Sr. Manager/Associate Director, Statistical ProgrammingBothell, WAFull TimeBiostatistics & Data ScienceSenior Manager/SupervisorShareSystImmune 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.
SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.SystImmune is seeking aSenior Manager or Associate Director of Statistical Programmingto 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 inPrinceton, NJ, or Bothell, WA.This is a bilingual role in Chinese and English.ResponsibilitiesResponsible for statistical programming activities within a therapeutic project or equivalentLead, manage, develop and support statistical programming teamManage 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 complexityAttend 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 agenciesDevelop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agenciesAssist statisticians by suggesting algorithms to address novel analysis requestsDevelop 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.RequirementsBSc 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 developmentAt least 5 years of experience as a statistical programming team leader or managerFluency in English and ChineseStrong knowledge of relevant regulatory (FDA, NMPA, EMA, PMDA etc.) and data submission guidelinesStrong understanding of drug development, including knowledge of interfaces and interdependencies with other functionsConsistent experience as a lead statistical programmer on several concurrent NDA projectsStrong knowledge of the relevant therapeutic areas and CDISC standardsSelf-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to statistical programming processes, management of statistical programmers and customer managementStrong project management skillsCompensation 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 thelow to mid-pointof the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.SystImmune is a leading and well-funded biotech company with a bright future.
We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. 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.We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.ShareApplyApply for this positionRequiredFirst NameLast NameEmail AddressPhoneAddressResume*We've received your resume.
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Try to be creative and say something that will catch our eye!150Are you fluent in Chinese?YesNoIn the last NDA or BLA you supported, what was your personal accountability as the lead statistical programmer, and what specific deliverable would have failed if you had not been involved?Describe one concrete decision you made as a programming lead or manager that directly prevented a missed regulatory or database lock deadline.Include what went wrong, what you changed, and the outcome. 3- 5 sentences should suffice.To continue, type the following sentence exactly as written, and also include the last word of the third bullet under Responsibilities in this job posting:“I confirm these responses are my own work and not generated by any AI tool.”Then write the extracted word from the third bullet point in box below.*The following questions are entirely optional.To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law.
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