Manager, Statistical Programming

Scorpion Therapeutics; Los Angeles (CA); On-site; USD 145,000 - 160,000; Full time

Job summary

Scorpion Therapeutics in Los Angeles, CA, is seeking a Biostatistician to support data analysis across clinical development. You will review analysis plans, develop ADaM datasets, program study analyses, and collaborate with cross-functional teams to ensure data quality throughout regulatory submission and post-approval activities.

The role requires a Master’s in Biostatistics, 4+ years of programming experience, and strong SAS skills with familiarity in R Studio; excellent written and verbal

Qualifications

• Master’s degree in Biostatistics/Statistics.
• 4 years of relevant programming experience in pharmaceutical or biotechnology drug development.
• Proficiency with SAS; familiar with R Studio.
• Excellent verbal and written communication skills; effective cross-functional collaboration and influence.
• Experience overseeing programming services of CRO vendors.
• Knowledge of cross-functional department functions/roles within a drug development company.

Responsibilities

• Review analysis plans for appropriate methodologies
• Review clinical data as SDTM datasets
• Develop analysis databases (ADaM)
• Program study analyses and review study results
• Conduct ad-hoc and exploratory statistical analysis and support manuscript preparation
• Communicate project requirements for data cleanup and data capture to ensure key variables are suitable for analysis
• Assist in developing and implementing departmental standards, applications, processes, and training
• Identify consultants/select service providers and oversee statistical and programming deliverables by CROs or service providers

Skills

Communication skills

Cross-functional collaboration

Education

Master’s degree in Biostatistics/Statistics

Tools

SAS

R Studio

Job description

Responsibilities

• Review analysis plans for appropriate methodologies
• Review clinical data as SDTM datasets
• Develop analysis databases (ADaM)
• Program study analyses and review study results
• Conduct ad-hoc and exploratory statistical analysis and support manuscript preparation
• Communicate project requirements for data cleanup and data capture to ensure key variables are suitable for analysis
• Assist in developing and implementing departmental standards, applications, processes, and training
• Identify consultants/select service providers and oversee statistical and programming deliverables by CROs or service providers

Requirements

• Master’s degree in Biostatistics/Statistics
• 4 years of relevant programming experience in pharmaceutical or biotechnology drug development
• Proficiency with SAS; familiar with R Studio
• Excellent verbal and written communication skills; effective cross-functional collaboration and influenceUnderstanding and experience across the clinical development life cycle through 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

Preferred

• Understanding of regulatory guidelines for CDISC dataset submission; experience developing SDTM and ADaM specifications

Compensation

California pay range: $145,000 USD - $160,000 USD

Eligibility

Candidates must have current, valid authorization to work in the country where this role is located.