Principal Biostatistician, Oncology

Gaithersburg, MD

Post Date: 09/11/2017 Job ID: 280964-0_1 Category: Pharmaceutical Salary: $130,000 to $140,000
Title: Principal Biostatistician
Location, Gaithersburg, MD
Salary: $130,000 to $140,000
Contact: Nikki Quist, nquist@smithhanley.com

Our Client Company is looking for a Principal Biostatistician responsible for delivery of global submissions with opportunity to be indication lead.

Responsibilities:

"Statistical Contribution for Project Indication Development Plans, Health Technology Assessment, Regulatory Strategy and Presentation
"Project lead with regards to external regulations and company standards
oDesign Options development and business support
oValue, Risk, and Benefit Quantifying for emerging Products
"Internal / External liaison to assure high quality standards of their deliverables
"Apply novel statistical approaches for value demonstration and regulatory guidance
"Statistical staff technical mentoring/coaching

Qualifications:

"PhD/MS in Biostatistics, Mathematics
"Experience in Healthcare/Pharma or relevant areas
"Oncology experience desired
"Regulatory and technical knowledge
"Development, Program Design, Interpretation and Data Analysis Experience
"Submissions and regulatory interaction experience
"Ability to build strong relationships- Polished Communication Skills



Nikki Quist
Executive Recruiter

Nikki concentrates her efforts on the nationwide placement of biostatisticians. Building relationships is her highest priority, allowing her to help candidates identify the career goal that best suits them, and help clients align their needs with the marketplace.
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