Senior Biostatistician

The Senior Biostatistician will provide statistical support (e.g., study design and data analysis) across all Portola’s clinical studies, pre-clinical, and validation studies. The successful candidate will provide data mining for product development, global regulatory submissions, claims substantiation, post market surveillance, and tracking data optimization. These activities are in direct support of product approval for Portola’s drugs.

 Responsibilities:

• Assist the Director of Biostatistics with the design and analysis of clinical trials in healthy volunteers and patients
• Provide biostatistics leadership to cross-functions, i.e. clinical science, project management, medical affairs, pharmacovigilance, and clinical operations
• Author statistical analysis plans for individual studies, ISS and ISE
• Provide input into CDISC standards across studies and programs
• Collaborate on project development plans, regulatory, scientific and commercial projects
• Assist with develop SOPs and ensure compliance with process & quality of deliverables within the development program
• Support publication activities and scientific presentations
• Maintain expertise in the field of biostatistics, and bring best practices and new methodologies in- house
• Author or contribute to reports and/or scientific presentations and manuscripts
• Perform statistical analysis, create summary tables, listings and figures in SAS and validate statistical analysis as defined in the analysis plan with oversight from supervisor
• Prepare analyses that support regulatory submissions for product approval
• Deliver results in a manner that is time-sensitive, high quality, proactive and communicative with collaborating entities and stakeholders
• Perform sample size and power calculations
• Assist in review of CRFs and edit checks; review and understand DM plans
• Develop and maintain department tools, templates, guidelines, SOPs and systems
• Work with Data Management partners to organize timely and accurate data extraction from EDC system into statistical programs for analysis

 Qualifications: 

• PhD in Statistics/Biostatistics or an equivalent degree with 2+ years’ experience in the device/pharma industry
• Expert level use of Statistical software including SAS
• Demonstrated ability to use of EDC/CTMS databases
• Knowledge of applied statistics for the purposes of regulatory submissions, claims substantiation and peer-reviewed publications
• Basic knowledge of Global Regulatory Requirements and Standards for statistical applications in the conduct of Clinical Research
• Proven ability to initiate process improvements and work in a matrix environment where cross-functional interaction is required
• Proven ability to deliver on delegated work efficiently
• Good interpersonal, collaborative and communication skills required
• Solid time management skills to meet deliverables commensurate with a fast-paced environment
• Well organized, able to multitask and prioritize competing tasks
• Able to manage expectations of supervisor, peers and customers