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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead complex projects, programs, and submissions
- Manage client meetings, CRMs, collaborate well with regulatory, PMs, and sponsors
- Develop SAPs and iSAPs text and shells with no supervision
- Produce and present external company presentations providing industry visibility
- Suggest solutions to solve issues in tune with organizational direction
- Review or develop ADAM specifications; work with programmers and junior statisticians to resolve comments
- Apply drug development knowledge during the production of complex statistical analyses
- Review or create the statistical section(s) of a Sponsor’s protocol and ensure appropriate statistical methods are proposed
- Provide valuable feedback to the Sponsor on the statistical aspects of the study
- Prepare and review statistical methods and results sections for the CSR independently
- Demonstrate an understanding of project management-related tasks such as timelines, scope and resource management
- Perform sample size calculations for various scenarios and study designs
- Provide statistical consulting support to sponsors regarding study design and sample size calculations
- Create randomization and kit schedules independently
- Collaborate with sponsors, randomization, and drug supply management teams
- Support Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician
- Stay current with the latest industry practices and regulatory guidelines
- Write blogs and/or white papers for posting on the company website
Requirements
What you’ll need- Masters in Biostatistics, Statistics discipline or related field, or related experience, PhD preferred
- Minimum of 7 years’ experience in Biostatistics, Statistics or similar field required
- Submission experience (ISS/ISE)
- High level knowledge of drug development as it pertains to biostatistics
- Expert knowledge of scientific principles and concepts
- Good communication skills and willingness to work with others to clearly understand needs and solve problems
- Good organizational skills
- High proficiency with MS Office applications
- Hands-on experience with clinical trial and pharmaceutical development preferred
- Excellent problem-solving skills
- Familiarity with current ISO 9001 and ISO 27001 standards preferred
- Familiarity with 21 CFR Part 11, FDA, and GCP requirements
- Good understanding of CROs and scientific & clinical data/terminology, & the drug development process
Benefits
Comp & perks- Great Place to Work certified organization
- Supportive and innovative team environment
- Industry best employee retention rate
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
BiostatisticsStatisticsADAM specificationssample size calculationsstatistical analysesstatistical methodsrandomizationclinical trial developmentpharmaceutical developmentdrug development knowledge
Soft Skills
communication skillsorganizational skillsproblem-solving skillscollaborationproject managementfeedback provisionindependencepresentation skillsconsulting supportsolution suggestion
Certifications
Masters in BiostatisticsPhD in Statistics or related field