Cynosure Staffing · 17 hours ago
Associate Director Biostatistics
San Diego, CA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
7+ years expCynosure Staffing is a late-stage autoimmune company focused on developing and commercializing small molecule therapies. They are seeking an Associate Director of Biostatistics who will serve as a study statistician for clinical studies, providing statistical input and contributing to clinical publication and regulatory submissions.
Staffing & Recruiting
Hiring Manager
Becky Krage
Responsibilities
Serve as a study statistician for assigned clinical studies related to one or more clinical programs
Provide statistically sound experimental design and data analysis strategies to meet project objectives with high quality in a timely manner
Provide statistical inputs on clinical development plans
Contribute to the development of clinical study protocols and author the statistical sections
Develop statistical analysis plans and work with programming to create table, listing and figure shells for clinical trials or ad-hoc analyses
Develop study randomization specification and verification documents as necessary
Perform sample size calculations and assess trial design operating characteristics under various assumptions. Advise the team on the most efficient design to meet study objectives
Review CRFs and edit checks and participate in UAT of different systems
Review dataset programming specifications, key derived variables, and statistical deliverables
Independently derive from source data key efficacy variables and analyses
Perform the analyses of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and the scientific community by contributing to the clinical study reports, clinical publications, conference posters and presentations
Review and contribute to study and project timeline and provide high quality statistical deliverables in a timely manner
Provide statistical leadership in clinical study team setting
Manage in-house and/or outsourced biostatistical activities and manage biostatistics vendors and contractors as necessary
Qualification
Required
Master's Degree or higher in Statistics, Biostatistics, or closely related field
7+ years for Master's degree and 5+ years for Ph.D. degree for experience in a drug-development environment
Knowledge of pharmaceutical and regulatory requirements, procedures, and policies
Knowledge of GCP, ICH, and other Guidance documents and policies related to clinical trials operations requirements
Proficiency in SAS software packages. Knowledge of CDISC requirements
Ability to program and oversee programming work performed by programming staff or vendors
Demonstrated ability to handle high volumes of work in a fluid, dynamic, and fast-paced environment
Demonstrated ability to work simultaneously on multiple projects, and to deliver high-quality work according to tight timelines
Excellent interpersonal, reading, writing, and communication skills, along with exceptional organizational skills
Strong problem and conflict-resolution skills
Travel up to 10%
Benefits
Annual bonus
Equity
Company
Cynosure Staffing
A boutique recruitment firm specializing in cell and gene therapy recruitment for both retained and contingent searches across the US, from stealth-mode start-ups to global biotechs.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase