Senior Biostatistician Consultant

Position Summary:

The Biostatistics Consultant will provide statistical support across one (or more) development program(s). This individual will be expected to operate in a hands-on capacity as well as work collaboratively across functional clinical and development teams as needed.

*Roles and Responsibilities of the Position:

• Works as the study statistician collaboratively with statistical programmers, other biostatisticians, clinical research associates, clinical data managers and other development functions to meet project and study deliverables for statistical data analysis and reporting.
• Ensures appropriate use and implementation of statistical methodologies.
• Prepares drafts of statistical documents (e.g., SAPs, TFL shells).
• Provides instructions for derivations and analyses to statistical programming, reviews TFLs to ensure quality of deliverables.
• Interacts with and oversees statistical vendors as needed.

Required Qualifications and Preferred Background:

• Required:
• PhD or MS degree in relevant field along with 3-4 years of direct experience in statistics/biostatistics within an industry setting within clinical development is required.
• Minimum 2 years related experience required.
• knowledge of clinical trial design, drug development regulations pertinent to statistical analysis, and sound understanding of statistical applications for clinical trials is required.
• Proficient SAS programming skills and solid understanding of CDISC models and standards
• Ideal candidate will also have:
• Previous NDA/BLA/MAA experience is preferred but not required.
• Ability to plan, multi-task, and shift priorities rapidly to meet tight deadlines.
• Excellent writing and communication skills along with excellent interpersonal skills.