Manager, Statistical Programming
Location
United States
Posted
16 days ago
Salary
$133.2K - $172.4K / year
Bachelor Degree7 yrs expEnglishGoogle Cloud Platform
Job Description
• Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
• Serves as project leader
• Generates or oversees the production of programming deliverables (e.g., tables, listings) for study reports and integrated summaries.
• Successfully interacts within Biometrics, with Clinical Development and Regulatory Affairs groups on a frequent basis
• Actively share experience and discuss possible process enhancements at programming meetings
• Recommends potential trainings
• Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures
• Responsible for all programming activities within a therapeutic project or equivalent
• Implements strategic initiatives
• Able to lead and manage multiple concurrent projects
Job Requirements
- BS degree in Biostatistics/Computer Science or equivalent and 7 years’ experience in pharma/biotech -OR - MS degree in Biostatistics/Computer Science or equivalent and 4 years’ experience in pharma/biotech –OR - PhD degree in Biostatistics/Computer Science or equivalent
- 2 years of experience in pharma/biotech
- Degree in Biostatistics/Computer Science or equivalent
- 6+ years of pharmaceutical/CRO experience
- Prior experience in oncology, hematology, and cell therapy is strongly preferred
- Knowledge of long term follow up trial knowledge strongly preferred
- Hands-on experience in pivotal studies and/or regulatory submissions (NDA, BLA, MAA, etc.)
- In-depth understanding of clinical programming and/or statistical programming processes and standards
- In-depth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH)
- Extensive experience with statistical programming using the SAS software including development and use of SAS Macros
- Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)
- Proven experience in leading programming activities
- Excellent interpersonal, communication, problem solving, and analytical skills.
Benefits
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
- Paid time off
- Company-sponsored medical, dental, vision, and life insurance plans
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