Associate Director, Biostatistics (Biomarker)

Location
San Francisco, CA, United States
Posted
Jun 12, 2018
Ref
2-3273-525-2018
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Summary:

Partner with molecular medicine scientists to conduct biomarker data analyses and proactively contribute to biomarker strategies in clinical drug development. This person shall have strong technical skills and extensive knowledge and experiences on biomarker analyses.

Responsibilities:

• Partner with molecular medicine scientists to conduct extensive exploratory biomarker data analyses and data mining
• Contribute to biomarker strategies in clinical drug development
• Assist biomarker-based adaptive designs when needed
• Support “biomarker-heavy” protocols and be responsible for biomarker analysis plans
• Conduct statistical simulations with minimal supervision
• Interpret biomarker analysis results in connection with clinical outcomes
• Review scientific literature
• Help develop protocols and clinical study reports
• Serve as a statistical consultant to scientists and Sr. management when needed
• Act as an integral member of project team, collaborate effectively with other team members, and attend project team meetings
• Perform statistical programming for advanced statistical methodologies
• Conduct quality review of statistical analyses
• Keep updated with regulatory requirements including good clinical practice guidelines
• Interact effectively with regulatory authorities

Requirements:

• Ph.D. in Biostatistics or Statistics with at least 6 years of pharmaceutical, biotechnology, or equivalent experience.
• Good understanding of advanced clinical trial design and biomarker analysis methodologies (data mining, statistical modeling, meta-analysis, etc.)
• Extensive knowledge and experiences on biomarker analyses
• Profound understanding of the roles biomarker plays in drug development
• Strong communication and interpersonal skills
• Work effectively in a cross-functional team
• Successfully completed a few clinical projects
• Ability to capture key information from scientific journal articles
• Understand regulatory requirements and good clinical practice guidelines
• Good statistical programming skills using R, SAS and other statistical software

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.