Confidential
Lead Statistical Programming Expert
Confidential, Los Angeles, California, United States, 90079
Base Pay Range:
$160,000.00/yr - $180,000.00/yr Position Overview:
We are looking for an accomplished Lead Statistical Programming Expert to join our dynamic biometrics team. In this key role, you will play a crucial part in supporting clinical studies within our expanding portfolio. You will serve as an internal expert in statistical programming, providing technical leadership and collaborating closely with various functional teams, including Clinical Development and Operations, Regulatory, Data Management, and Medical Affairs. Key Responsibilities: Evaluate analysis plans to ensure appropriate methodologies are employed. Review clinical data in SDTM datasets. Develop analysis databases (ADaM) for studies. Program study analyses and critically review study results. Conduct ad-hoc and exploratory statistical analyses to support manuscript preparation. Communicate project requirements for data cleanup and capture, ensuring key study variables are ready for analysis. Contribute to the development and implementation of departmental standards, applications, processes, and training. Assist in identifying and selecting consultants and service providers, ensuring oversight of statistical and programming deliverables by CROs or external partners. Qualifications: Master's degree in Biostatistics or a related field with a minimum of 4 years of experience in pharmaceutical or biotechnology drug development. Proficient in statistical software, particularly SAS, and familiarity with R Studio. Exceptional verbal and written communication skills, with a proven ability to collaborate effectively across different teams. Comprehensive knowledge of the clinical development lifecycle, including regulatory submissions and post-approval activities. Experience managing and overseeing programming services from CRO vendors. Understanding of cross-functional roles within a drug development context. Preferred Skills: Knowledge of regulatory guidelines regarding the submission of datasets using CDISC, and experience developing SDTM and ADaM specifications.
$160,000.00/yr - $180,000.00/yr Position Overview:
We are looking for an accomplished Lead Statistical Programming Expert to join our dynamic biometrics team. In this key role, you will play a crucial part in supporting clinical studies within our expanding portfolio. You will serve as an internal expert in statistical programming, providing technical leadership and collaborating closely with various functional teams, including Clinical Development and Operations, Regulatory, Data Management, and Medical Affairs. Key Responsibilities: Evaluate analysis plans to ensure appropriate methodologies are employed. Review clinical data in SDTM datasets. Develop analysis databases (ADaM) for studies. Program study analyses and critically review study results. Conduct ad-hoc and exploratory statistical analyses to support manuscript preparation. Communicate project requirements for data cleanup and capture, ensuring key study variables are ready for analysis. Contribute to the development and implementation of departmental standards, applications, processes, and training. Assist in identifying and selecting consultants and service providers, ensuring oversight of statistical and programming deliverables by CROs or external partners. Qualifications: Master's degree in Biostatistics or a related field with a minimum of 4 years of experience in pharmaceutical or biotechnology drug development. Proficient in statistical software, particularly SAS, and familiarity with R Studio. Exceptional verbal and written communication skills, with a proven ability to collaborate effectively across different teams. Comprehensive knowledge of the clinical development lifecycle, including regulatory submissions and post-approval activities. Experience managing and overseeing programming services from CRO vendors. Understanding of cross-functional roles within a drug development context. Preferred Skills: Knowledge of regulatory guidelines regarding the submission of datasets using CDISC, and experience developing SDTM and ADaM specifications.