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Director, Biostatistics

Chicago, IL 60611

Posted: 05/01/2023 Category: Pharmaceutical Job Number: 283083-0_1 Salary: $200,000 - $220,000

Job Description

Smith Hanley Associates
Director, Biostatistics
Remote/Permanent
Nihar Parikh- [email protected]

Responsibilities:
Work closely with internal and external functions, including Programming, Data Management, Regulatory Affairs, and Project Management.
Manage direct reports, assign workflow, and oversee vendors.
Interact directly with sponsors as part of the study team and for business development.
Review and input into the statistical aspects of protocols, regulatory submissions, clinical study reports, etc.
Responsible for all aspects of statistical analyses of clinical trials data, Phases 1-4, including development of statistical analysis plan and mock shells. In addition, creating TLF's, sample size estimation; randomization schedules, etc.
Serves as core team member for multiple projects including supervising the initiation, planning, and execution of all statistics related tasks.
Drive SOPs, standardization efforts, methods, techniques and evaluation criteria for projects.
Serve as the Statistical Quality Reviewer for statistical analyses, sample sizes, and outputs.
Perform QC of statistical data/outputs.
Coordinate and develop statistical information for reports submitted to the FDA.
Provide statistical scientific expertise to resolution of issues related to development activities for major functional areas.

Requirements:
Advanced degree in Biostatistics, Statistics, or related field.
10+ years of work experience in clinical research, with experience in Phase 1 - 3 clinical studies. Strong experience in the design, execution, and data analysis of clinical studies.
People management experience required.
Strong SAS programming skills.
Experience with clinical product development in the pharmaceutical industry.
Strong analytical skills, as well as interpreting scientific research and literature.
Experience with ICH guidelines and GCP required.

www.smithhanley.com

Meet Your Recruiter

Nihar Parikh
Executive Recruiter

Nihar specializes in the clinical domain and works across biostatistics, clinical trials/research, data management, health economics/RWE, medical affairs, statistical programming, and other R&D areas within pharma and biotech. He has more than ten years of recruiting experience and attributes his success to the ability to build good relationships, listen attentively, be proactive, continuously self-improve, and show empathy. Nihar plans to carry Smith Hanley’s stellar reputation in the pharma business for many years to come. Outside of work, Nihar likes to spend his time following Chicago sports, travel, podcasts, yoga, golf, and investing. 

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