SystImmune · 2 weeks ago
Associate Director, Statistical Programming
Redmond, WA
Full-time
Onsite
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. The Associate Director of Statistical Programming provides strategic leadership and operational oversight of statistical programming activities across clinical studies, ensuring compliance with regulatory guidelines and organizational standards.
BiopharmaBiotechnologyProfessional Services
Responsibilities
Contribute to team building, departmental strategic planning, resource forecasting or support organizational growth and operational excellence
Lead the development, validation, and maintenance of Standard Operating Procedures (SOPs), programming guidelines, and technical documentation to ensure consistency and compliance across all programming activities
Develop and implement both short-term and long-term strategies for statistical programming that align with the organization’s scientific and operational objectives, including establishing goals, metrics, and progress monitoring
Provide expert guidance on statistical programming best practices, programming standards, and automation strategies. Ensure timely, high-quality delivery of statistical programming outputs, including SDTM and ADaM datasets, Define.xml, tables, listings, and figures (TLFs) in compliance with CDISC, ICH, FDA, and EMA standards
Lead, mentor, and develop a team of programmers and managers, fostering a high-performance, accountability, and collaborative culture
Manage programming support for regulatory submissions, clinical study reports, publications, exploratory analyses, and ad hoc requests
Oversee the full lifecycle of programming activities across clinical studies both internally and externally - from planning and development to execution, validation, and delivery
Qualification
Required
Master's degree or higher in Statistics, Biostatistics, Computer Science, Mathematics, or a related scientific discipline with a minimum of 10 years of experience in statistical programming within the pharmaceutical industry
At least 2+ years of experience as a Lead/Program/Project Programmer for one or more programs/indications, including the coordination of large teams of internal and/or external programmers
Proven experience overseeing statistical programming activities for clinical trials and regulatory submissions and in-depth understanding of clinical development processes, including data standards, regulatory requirements, and statistical methodologies
Advanced proficiency in SAS programming, with hands-on experience in developing and validating SDTM and ADaM datasets, Define.xml, and statistical outputs (tables, listings, and figures)
Strong knowledge of CDISC standards (SDTM, ADaM), ICH guidelines, and global regulatory agency requirements (e.g., FDA, EMA, NMPA, and PMDA)
Strong strategic planning, organizational, and problem-solving skills, and excellent communication and interpersonal skills
Preferred
3+ years' experience in management or equivalent leadership experience is preferred but not required
Benefits
100% paid employee premiums for medical/dental/vision
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
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
Represents job field similar to this job
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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