Lead Biostatistician- Remote

Chicago, IL 60606

Posted: 05/03/2021 Category: Pharmaceutical Job Number: 281785-50_1

Job Description

Smith Hanley Associates
Lead Biostatistician (Senior or Principal)
Nihar Parikh - [email protected]

Our client, a leading global CRO, has multiple openings for Lead Biostatisticians- Senior or Principal level. In this role you will be the key client contact, oversee complex protocols and NDAs, while working with regulatory agencies. Great opportunity to act as the SME and lead in providing statistical, process and regulatory knowledge. Option to work onsite across multiple offices or fully remote.

-Provide oversight of statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, and report preparation
-Serve as a project lead, perform project management functions, as well as oversee study design
-Review specifications for analysis database, supervise creation of table and listing specifications, and assure completeness for use in programming
-Review sample size calculations and protocols, randomization related documentation, and statistical analysis for key efficacy endpoints
-Write or review statistical analysis plans and provide guidance on its implementation
-Lead team members across projects, work closely with the sponsor as well as regulatory agencies, and oversee budgets
-Implement strategies to ensure process and programming efficiencies on complex studies
-Prepare reports, manuscripts, and other documents

-Advanced degree (MS/PhD) in Biostatistics, Mathematics, Statistics or similar field and strong statistical as well as consulting skills
-5+ years of experience in a CRO and experience leading clinical trials
-Strong knowledge of clinical trials design and analysis, regulatory guidelines and advanced SAS programming
-Experience creating study specifications and providing support in the review of data management documentation
-Strong understanding of the regulatory issues associated with the reporting of clinical data in the submission process
-Strong project management and mentoring skills

Smith Hanley Associates is a recruiting agency with expertise in Biostatistics and other areas.


Meet Your Recruiter

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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