Confidential ยท 22 hours ago
Manager Biostatistics
San Diego, CA
Full-time
Onsite
Senior Level
$130K/yr - $180K/yr
5+ years expConfidential company is seeking a stellar biostatistician to join their rapidly growing biometrics team to support clinical studies across their expanding portfolio. As an internal expert in biostatistics, you will provide technical leadership and biostatistical input to collaborate with other functional teams in the drug development process.
Staffing & Recruiting
Responsibilities
Provide sound statistical and operational input, including study and program design, writing of the protocol sections, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications
Partner with cross functional teams to provide strategic biostatistics input to support entire drug development process; ensure statistical integrity of all key deliverables
Provide statistically sound scientific methodology for study design and data analysis input to meet project objectives in accordance to regulatory guidance and industry standards
Collaborate with the programming and data management functions to ensure appropriate data collection and reporting
Provide leadership in evaluating alternative or innovative methods of study design and analysis
Assist in efforts to identify, develop and implement departmental standards, applications, processes and training
Oversees statistical and programming deliverables by CROs
Assist in identifying consultants and the selection of service providers
Qualification
Required
PhD in Biostatistics or a related field
5 years of relevant experience in pharmaceutical or biotechnology drug development
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 biometrics services of CRO vendors
Proficiency in the use of statistical software including SAS and R at minimum; familiarity with East and Sportfire
Excellent verbal and written communication skills
Knowledge of pharmaceutical clinical development processes and ability to effectively apply technical principles and methods to clinical drug development
Effective in communication and team collaboration, influencing across different functional lines
Knowledge of cross-functional department functions/roles within a drug development company
Preferred
Understanding of regulatory guidelines related to submission of datasets using CDISC, development of SDTM and ADaM specifications
Company
Confidential
Hiring
Mumbai, Maharashtra, IN
2-10 employeesFunding
Current Stage
Early StageCompany data provided by crunchbase