Senior Director, Statistical Programming
Immunome, Inc.
1 month ago
Remote friendly (Bothell, WA)
United States
$271,754 - $305,050 USD yearly
Clinical Research and Development
Position Overview
The Senior Director of Statistical Programming provides leadership and oversight across clinical programs within Statistical Programming. Manages programming resources; supports development of programming infrastructure and process; provides technical support and guidance for regulatory submissions while adhering to CDISC standards and submission requirements; oversees CRO partners; drives technology innovation and cross-functional leadership.
Responsibilities
- Provide leadership and line management to the Statistical Programming function.
- Manage and oversee statistical programming resources (FTEs, contractors, and CROs) for early- and late-stage studies.
- Ensure quality and timeliness of statistical analysis, reporting, and regulatory submission deliverables; provide hands-on programming for critical ADAMs and TLFs when required.
- Promote best practices related to programming environments, technology, and programming skillsets.
- Develop and ensure conformance to Programming SOPs and Work Practice guidelines.
- Maintain strategy for capability and skill development.
- Foster creativity and transparency with a framework for continuous improvement.
- Drive standardization and innovation.
Qualifications
- PhD or Master in Biostatistics, Statistics, Computer Science, or related field.
- 15+ years’ experience in pharmaceutical/biotech/CRO industry; 5+ years leadership experience strongly preferred.
- Significant oncology experience required.
Knowledge and Skills
- Track record leading/overseeing global regulatory submissions in oncology.
- Proficiency in statistical programming languages (e.g., SAS, R).
- Experience with reporting processes, regulatory requirements, and software development life cycle.
- Strong leadership, interpersonal, organizational, and cross-functional collaboration skills.
- Strong communication skills for aligning complex technical decisions.
- Proven experience developing and leading high-performing teams.
- Ability to multi-task, prioritize, anticipate challenges, identify/resolve issues, and influence the team positively.
- Collaborative, innovative, high-energy approach.
Washington State Pay Range
- $271,754 - $305,050 USD
The Senior Director of Statistical Programming provides leadership and oversight across clinical programs within Statistical Programming. Manages programming resources; supports development of programming infrastructure and process; provides technical support and guidance for regulatory submissions while adhering to CDISC standards and submission requirements; oversees CRO partners; drives technology innovation and cross-functional leadership.
Responsibilities
- Provide leadership and line management to the Statistical Programming function.
- Manage and oversee statistical programming resources (FTEs, contractors, and CROs) for early- and late-stage studies.
- Ensure quality and timeliness of statistical analysis, reporting, and regulatory submission deliverables; provide hands-on programming for critical ADAMs and TLFs when required.
- Promote best practices related to programming environments, technology, and programming skillsets.
- Develop and ensure conformance to Programming SOPs and Work Practice guidelines.
- Maintain strategy for capability and skill development.
- Foster creativity and transparency with a framework for continuous improvement.
- Drive standardization and innovation.
Qualifications
- PhD or Master in Biostatistics, Statistics, Computer Science, or related field.
- 15+ years’ experience in pharmaceutical/biotech/CRO industry; 5+ years leadership experience strongly preferred.
- Significant oncology experience required.
Knowledge and Skills
- Track record leading/overseeing global regulatory submissions in oncology.
- Proficiency in statistical programming languages (e.g., SAS, R).
- Experience with reporting processes, regulatory requirements, and software development life cycle.
- Strong leadership, interpersonal, organizational, and cross-functional collaboration skills.
- Strong communication skills for aligning complex technical decisions.
- Proven experience developing and leading high-performing teams.
- Ability to multi-task, prioritize, anticipate challenges, identify/resolve issues, and influence the team positively.
- Collaborative, innovative, high-energy approach.
Washington State Pay Range
- $271,754 - $305,050 USD