Lead Biostatistician, IVD

Hologic•San Diego, CA

2d•Onsite

About The Position

The Lead Biostatistician leads the development of statistical programs, performs complex analyses, and ensures CRF and database design meets advanced analysis needs. The position provides high-level statistical support across departments, authors statistical analysis plans, and maintains expertise in current statistical techniques. This is an onsite role in San Diego, California. The role works with Clinical Affairs and other project team members on statistical methods, clinical protocol design, data collection and analysis needs, and the presentation and interpretation of results. It also supports regulatory submissions and provides statistical expertise to departments including R&D, QA, QC, Marketing, and Manufacturing.

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 a master’s degree, or at least 1 year with a Ph.D.
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 project team members in Clinical Affairs to ensure CRF and database design meets analysis needs.
Develop statistical programs to perform analyses and present results.
Work with SAS programmers to ensure appropriate data analysis and presentation.
Provide input on Biostatistical and Data Management SOPs and work instructions.
Recommend and implement continuous process improvement ideas.
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 for regulatory submissions.
Serve as a resource for other departments on experimental design, sample size, statistical analysis, and interpretation of results.
Maintain expertise in current statistical analysis techniques and learn new techniques.