Description:
Job Title: Associate Director/Director, Statistical Programming
Company: Immunome, Inc.
Location: Bothell, WA
Company Overview
Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including small molecules, ADCs, and RLTs. We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.
Position Overview
The Associate Director/Director, Statistical Programming is a leadership role that involves overseeing statistical programming activities within clinical trials. This position collaborates closely with cross-functional teams, including biostatistics, data management, and clinical operations. Here are the key responsibilities and qualifications:
Responsibilities
Statistical Programming Oversight and Hands-On Programming
- Lead and manage statistical programming teams (both internal and external) to ensure timely and high-quality deliverables.
- Review and approve programming plans, specifications, and outputs.
- When necessary, engage in hands-on statistical programming using tools such as SAS.
- Develop and validate programs for data analysis, reporting, and visualization.
- Ensure adherence to regulatory guidelines and industry standards.
Leadership and Strategy
- Provide strategic direction for statistical programming activities across multiple studies or projects.
- Collaborate with stakeholders to define programming standards, processes, and best practices.
Collaboration and Communication
- Work closely with biostatisticians, clinical teams, and other stakeholders.
- Provide statistical expertise during study design, data analysis, and reporting.
Quality Control
- Perform quality checks on programming outputs, ensuring accuracy and consistency.
- Address any discrepancies or issues promptly.
Vendor Management
- Oversee programming activities outsourced to external vendors.
- Monitor vendor performance and ensure compliance with project timelines.
Process Improvement
- Identify opportunities for process optimization and standardization.
- Implement best practices and ensure consistency across projects.
- Stay updated on industry trends, new methodologies, and emerging technologies.
Requirements:
Education and Experience:
- Master in Biostatistics, Statistics, or a related field.
- At least 7 years of statistical programming experience in the pharmaceutical, biotech, or CRO industry.
Knowledge and Skills
- Prior experience in regulatory submissions (e.g. NDA, BLA) a strong plus.
- Proficiency in statistical programming languages (e.g., SAS, R).
- Strong understanding of clinical trial data and regulatory requirements
- Knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines.
- Comprehensive knowledge of the CDISC standards and concepts, and the current best practice in the industry.
- Excellent leadership, communication, and problem-solving skills.
- Attention to detail including proven ability to manage some competing priorities.
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Salary Range
$170,000 - $228,300
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