What are the responsibilities and job description for the Senior Manager, Statistical Programming position at Exokeryx, Inc.?
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The Senior Manager, Statistical Programming will be responsible for leading and managing the statistical programming activities for clinical trial data collection, analysis, reporting, and visualization, with a primary focus on oncology studies. This role will oversee the development and implementation of statistical programming strategies, manage a team of statistical programmers, and collaborate closely with cross-functional teams to ensure high-quality deliverables that meet regulatory requirements and support drug development efforts.
Role and Responsibilities :
- Lead and manage statistical programmers, providing mentorship, technical guidance, and career development opportunities.
- Develop and implement statistical programming strategies and best practices for clinical trials across all phases, ensuring alignment with company goals, industry standards, and regulatory requirements.
- Oversee the creation and validation of CDISC-compliant SDTM and ADaM datasets, with a focus on oncology-specific data structures and endpoints.
- Collaborate with Biostatistics to implement complex statistical analyses for oncology trials, including time-to-event analyses, response evaluations, and biomarker assessments.
- Direct the development of tables, listings, and figures (TLFs) for clinical study reports, regulatory submissions (including NDA / BLA), and publications.
- Ensure compliance with FDA, EMA, PMDA and other regulatory agency requirements for statistical programming deliverables in submissions.
- Lead the development and maintenance of standardized oncology-specific analysis datasets, programs, and macros to improve efficiency and consistency across projects.
- Manage resource allocation, project timelines, and deliverables for multiple studies simultaneously, including outsourced work to CROs.
- Serve as the statistical programming representative in cross-functional study teams and external collaborations.
- Contribute to the development and improvement of department SOPs, working instructions, and quality control processes.
- Stay current with evolving trends in oncology clinical trials, statistical methodologies, and programming techniques, and implement innovative approaches as appropriate.
- Contribute to regulatory interactions and represent statistical programming in regulatory meetings when needed.
- All other duties as assigned.
Experience, Education and Specialized Knowledge and Skills :
Preferred Qualifications :
The pay range for this role is $170,000-$190,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and / or other applicable variable compensation.
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Salary : $170,000 - $190,000
