Associate Director or Director, Biostatistics

About CymaBay Therapeutics:

CymaBay is a clinical-stage biopharmaceutical company focused on improving the lives of people with liver and other chronic diseases that have high unmet medical need through a pipeline of innovative therapies.

Position Summary:

This position will serve as a lead biostatistician for one or more clinical studies. The position will provide statistical support for study design, develop statistical analysis plan (SAP), oversee execution of SAP, perform ad hoc analysis, collaborate with study team to support clinical development, support ISS/ISE and other NDA activities. This position will report to the VP of Biometrics.

Functions and Job Responsibilities:

• Lead biostatistics activities in a phase 3 or phase 4 study, with accountability of biostatistics deliverables, including biostatistics support of clinical development planning, clinical study designs, protocol development, analysis planning/execution, clinical study report table/figure/listings, statistical interpretations, and regulatory submission activities.
• Provide biostatistics leadership and perform study data reviews during clinical studies conduct 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

Qualifications:

• Master or PhD in statistics or equivalent, with at least 8 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.

The anticipated salary range for Associate Director candidates who will work in Newark, California is $185,000 - $200,000 and for Director candidates is $215,000 - $235,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. CymaBay is a multi-state employer, and this salary range may not reflect positions that work in other states.