Lead Biostatistician, IVD

Hologic • San Diego, CA

3d • $102,500 - $160,300 • Onsite

About The Position

The Lead Biostatistician leads development of statistical programs, performs complex analyses, and ensures CRF and database design supports advanced analysis needs. The role provides high-level statistical expertise across departments, authors statistical analysis plans, and maintains expertise in current statistical techniques. This is an onsite position in San Diego, California.

Requirements

• Master's degree or higher in Statistics, Biostatistics, or a related field such as Epidemiology.
• At least 3 years of progressive, relevant experience with an MS, or at least 1 year with a PhD.
• Working knowledge of CRF and database development, including attribute assignment and logic checking.
• Advanced knowledge of statistical software such as SAS, JMP, or R.
• Knowledge of FDA regulatory requirements for IDE, BLA, PMA, and 510(k) submissions.
• Advanced knowledge of applied statistical methods for clinical trials.
• Knowledge of applied statistical methods for design of experiments and quality control.
• Knowledge of infectious disease, cancer, genomics, and common public health issues.
• Experience in technical writing.

Responsibilities

• Provide biostatistical expertise to Clinical Affairs staff and determine appropriate statistical methods and procedures.
• Work with Clinical Affairs project team members to ensure CRF and database design meets analysis needs.
• Develop statistical programs to perform analyses and present results, and work with SAS programmers to ensure appropriate analysis and presentation.
• Provide input on Biostatistical and Data Management SOPs and work instructions, and recommend and implement continuous process improvements.
• Write statistical analysis plans (SAPs) and develop table, listing, and graph shells for statistical analyses and reports.
• Interface with clinical investigators to determine protocol design.
• Write statistical and data analysis sections of regulatory submissions.
• Serve as a resource for other departments, including R&D, QA, QC, Marketing, and Manufacturing, on statistical issues such as experimental design, sample size, analysis, and interpretation.
• Maintain expertise in current statistical analysis techniques and actively learn new techniques.

Benefits

• Comprehensive training upon joining and continued development and training throughout the career.
• Bonus eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior