Lead Biostatistician
1-Year Remote contract | May Start | Leading Global CRO | FSP Model
We are partnering with a leading Contract Research Organization to identify an experienced Lead Biostatistician for a 12-month remote contract engagement beginning in May. This is an exciting opportunity to lead high-impact clinical projects within a collaborative, fast-paced research environment.
Position Overview
The Lead Biostatistician will act as the lead statistician on projects of moderate to large size and complexity and will support senior statisticians on large, complex studies. This role may include staff management and/or project management responsibilities.
Key Responsibilities
* Serve as Lead Statistician on assigned studies
* Lead cross-functional project teams by:
* Conducting team meetings
* Managing timelines and deliverables
* Assessing and allocating resources
* Preparing and managing project budgets
* Ensure adherence to Standard Operating Procedures (SOPs) and maintain comprehensive project documentation
* Coordinate with programming and data management teams regarding database maintenance, updates, and documentation
* Provide guidance on database structures for statistical analysis
* Develop specifications for analysis datasets based on Data Management databases
* Perform sample size calculations
* Review study protocols for completeness, appropriate clinical design, and statistical rigor
* Develop randomization schemes and supporting documentation
* Author and oversee Statistical Analysis Plans (SAPs), including tables, listings, and figures
* Program and/or validate statistical tables, with emphasis on efficacy endpoints
* Oversee and review programming work conducted by other team members
* Prepare and review statistical reports, including statistical methods sections
* Act as primary statistical contact for sponsors
* Monitor project scope and budget; proactively communicate potential changes
Qualifications
* MS or MA in Statistics, Biostatistics, Mathematics, or related field
* Minimum of 2 years of relevant industry experience (or equivalent combination of education and experience)
* Experience leading projects and/or managing team members preferred
Required Skills & Competencies
* Strong SAS programming expertise and solid understanding of database structures
* In-depth knowledge of statistical principles and clinical trial methodology
* Proven ability to manage multiple projects and priorities
* Strong leadership and team collaboration skills
* Excellent written and verbal communication skills
* Highly organized with the ability to adapt to shifting priorities
* Positive, solution-oriented mindset
Apply now to be considered for this exciting opportunity and take the lead on impactful clinical research projects with a global CRO.