Manager, Statistical Programming
$145,000–$160,000 year
On-sitePasadena, California, United States
Job Summary
Review analysis plans for appropriate methodologies and clinical data as SDTM datasets. Develop analysis databases (ADaM) and program study analyses while reviewing results. Conduct ad-hoc and exploratory statistical analysis to support manuscript preparation. Communicate project requirements for cleanup and data capture to ensure key study variables are suitable. Assist in identifying consultants, selecting service providers, and overseeing statistical deliverables by CROs. Establish departmental standards, applications, processes, and training. Collaborate with Clinical Development, Operations, Regulatory, Data Management, Medical Affairs, and Program Management teams. Lead technical expertise in statistical programming for clinical studies across the expanding portfolio.
Required Qualifications
- Master's degree in Biostatistics/Statistics
- 4 years of relevant programming experience in pharmaceutical or biotechnology drug development
- Proficiency in the use of statistical software including SAS
- familiarity of the use of R studio
- Excellent verbal and written communication skills
- Effective in communication and team collaboration, influencing across different functional lines
- Understanding and experience with various aspects of a clinical development life-cycle, leading up to regulatory submission and post -approval activities
- Experience interacting with and overseeing programming services of CRO vendors
- Knowledge of cross-functional department functions/roles within a drug development company
- Candidates must have current, valid authorization to work in the country where this role is located
Desired Qualifications
- Understanding of regulatory guidelines related to submission of datasets using CDISC
- development of SDTM and ADaM specifications
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