Associate Director, Biostatistics

Southport, CT 06890

Posted: 06/10/2019 Category: Pharmaceutical Job Number: 281504-21_1
Smith Hanley Associates
Associate Director, Biostatistics
Southport, CT
Nihar Parikh, [email protected]

Our client is a privately held global pharma organization. In this role you will lead statistical aspects of clinical study design, provide regulatory guidance, and provide project leadership as the lead statistician.

-Oversee clinical development plans, statistical protocol and study design
-Develop SAP's, clinical reports and provide strategic guidance
-Lead regulatory requirements, CSR review, and statistical deliverables
-Manage statistical programming, data collection and analysis
-Monitor compliance with data standards such as CDISC, TLF reports, as well as data reporting procedures
-Interact with stakeholders and provide statistical insights
-Collaborate with teams to evaluate new drug candidates and provide statistical expertise to due diligence projects
-Maintain adherence to industry standards, regulatory guidelines and SOP's
-Manage project activities, statistical resources, and optimize resource utilization

-MS/PhD in Biostatistics, Statistics or related field and experience in the pharmaceutical industry
-Strong statistical methodology, clinical development and regulatory guidance
-Experience in SAS programming, clinical trial design, statistical analysis plans and life cycle management
-Hands on experience with advanced statistical concepts
-Experience managing CRO's and working with cross functional teams
-Proven technical leader and exceptional project management skills

Smith Hanley Associates is a niche recruiting agency.


Nihar Parikh
Executive Recruiter

Nihar manages recruiting in biostatistics and other clinical areas. He likes recruiting because it allows him to impact a company’s greatest asset, their employees.  

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