Associate Director of Biostatistics - Grand Prairie Texas

Company: VirtualVocations
Location: Grand Prairie, Texas
Posted On: 01/23/2025

A company is looking for an Associate Director of Biostatistics to provide strategic and technical leadership for clinical trials.



Key Responsibilities

Develop statistical analysis plans and review CRFs, TFL shells, and specifications
Manage CRO activities to ensure high-quality statistical analyses and outputs
Collaborate with cross-functional teams on product development strategies and advance department standards


Required Qualifications

Ph.D. in Biostatistics/Statistics with 8+ years or M.S. with 10+ years of experience in biostatistics within the pharmaceutical industry
Proficiency in statistical methods for all phases of clinical trials and familiarity with regulatory guidance (e.g., ICH, FDA, EMA)
Hands-on experience with CDISC standards (SDTM, ADaM) and statistical software (SAS, R, Python)
Strong track record in leading statistical contributions for NDAs/BLAs/MAAs, including regulatory interactions
Ability to thrive in a fast-paced environment More...

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