Director/Associate Director, Biostatistician
CymaBay is a clinical stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases.
If you are ready to join a team where your work is challenging, rewarding and meaningful; where your efforts are recognized and appreciated; where your career and skills are developed and expanded; AND where you are truly VALUED…
then CymaBay is looking for YOU!
To help us achieve our mission we are seeking a talented Director/ Associate Director, Biostatistician to join our team. The position will provide statistical support for study design, develop statistical analysis plan (SAP), oversee execution of SAP, performed ad hoc analysis, collaborate with study team to support clinical development, and participate in NDA.
Essential Functions and Job Responsibilities:
- Support biostatistics project lead, with accountability of biostatistics deliverables, including biostatistics support of clinical development planning, clinical study designs, protocol writing, analysis planning/execution, clinical study report table/figure/listings, statistical interpretations, and regulatory submission activities
- Provide leadership and perform study data reviews during clinical studies to ensure that clinical studies are in the right course as planned with proper checking of data quality
- Collaborate with cross functional team to facilitate and optimize the clinical development and registration process to meet deliverables and timelines for statistical data analysis and reporting
- Manage biostatistics vendors, identify potential risks and address issues
- Perform and/or validate statistical analysis to support publication and conference presentation
- Assist non-routine projects as applicable in support of drug development activities
- Participate in NDA preparation and submission
- Complete other responsibilities as assigned
- Master or PhD in statistics or equivalent, with at least 5 years of relevant experience in biotechnology or pharmaceutical industry
- Excellent interpersonal and communication skills
- Extensive knowledge of GCP, ICH guidelines, FDA regulations
- Good knowledge and skills of programming in SAS.
- Demonstrated ability in providing statistical input and direction in clinical study designs, statistical approaches, interpretation of findings and crafting of key messages