Associate Director, Statistical Programming

Systimmune • Redmond, WA

9d • $150,000 - $200,000 • Onsite

About The Position

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. 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. The Associate Director of Statistical Programming provides strategic leadership and operational oversight of statistical programming activities across clinical studies. This role is responsibility for providing direction of programming operations and ensures that all programming, validation, and data governance processes are conducted in compliance with regulatory guidelines and organizational standards. The directory works closely with cross functional teams and collaborators to align analysis methodologies, resource planning and project priorities. Success in this role requires strong leadership, team building, and collaboration skills to drive excellence in data quality, operational performance, and program delivery. This position can be located at our Redmond, WA or Princeton, NJ office locations.

Requirements

• 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.

Nice To Haves

• 3+ years’ experience in management or equivalent leadership experience is preferred but not required.

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 11-50 employees