Manager/Sr. Manager, Biostatistics

• 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

• PhD in Biostatistics/Statistics
• 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

Understanding of regulatory guidelines related to submission of datasets using CDISC, development of SDTM and ADaM specifications

competitive salaries and an excellent benefit package