Lead Biostatistician, IVD

Hologic, Inc.; San Diego (CA); On-site; USD 103,000 - 160,000; Full time

Job summary

Hologic, Inc. seeks a Lead Biostatistician to lead statistical program development, perform complex analyses, and ensure CRF/database design meets advanced analysis needs.

The role provides high-level statistical support across departments and authors SAPs while staying at the forefront of statistical techniques. This onsite position in San Diego, CA requires MS in statistics/biostatistics with 3+ years (MS) or 1+ years (PhD) experience and expertise in SAS/JMP/R, regulatory submissions, and

Qualifications

• MS in Statistics, Biostatistics, or related field (eg., Epidemiology).
• 3+ years (MS) or 1+ years (PhD) of progressive and relevant experience.
• Working knowledge of CRF and database development, including attribute assignment and logic checking.
• Advanced knowledge of FDA regulatory requirements for IDE, BLA, PMA and 510K submissions.
• Advanced knowledge of applied statistical methods for clinical trials.
• Knowledge of infectious disease, cancer, genomics and public health issues.
• Experience in technical writing.

Responsibilities

• Provides biostatistical expertise to Clinical Affairs staff; determines appropriate statistical methods and procedures.
• Develops statistical programs to perform analyses; works with SAS programmers to ensure proper data analysis.
• Writes SAPs and develops table/listing/graph shells for analyses and reports.
• Interfaces with investigators to determine protocol design.
• Writes the statistical and data analysis sections in regulatory submissions.
• Acts as a resource for other departments regarding statistical issues and experimental design.
• Maintains expertise in current statistical techniques and learns new methods.

Skills

Biostatistics

Clinical trials

Regulatory knowledge

Education

MS in Statistics/Biostatistics

Tools

SAS

JMP

R

Job description

Join our dynamic team and make a lasting impact on patients’ lives through innovative clinical evidence.

The Lead Biostatistician is responsible for leading the development of statistical programs, performing complex analyses, and ensuring CRF and database design meet advanced analysis needs. Additionally, this role involves providing high-level statistical support across various departments, authoring comprehensive statistical analysis plans, and staying at the forefront of current statistical techniques.

This is an onsite position in San Diego, CA.

Essential Duties and Responsibilities

• Provides biostatistical expertise to Clinical Affairs staff; determines appropriate statistical methods and procedures.
• Works with other project team members in Clinical Affairs to ensure CRF and database design meets analysis needs.
• Develops statistical programs to perform statistical analysis and present results. Work with SAS programmers to ensure appropriate data analysis and presentation is performed.
• Provides input on Biostatistical and Data Management SOPs and work instructions. Recommends and implements continuous process improvement ideas.
• Writes statistical analysis plans (SAPs) and develops table/listing/graph shells for statistical analyses and reports.
• Interfaces with clinical investigators to determine protocol design.
• Writes the statistical and data analysis sections in regulatory submissions.
• Acts as a resource for other departments (e.g., R&D, QA, QC, Marketing, Manufacturing) regarding statistical issues including experimental design, sample size, statistical analysis and interpretation of results.
• Maintains expertise in current statistical analysis techniques and actively learns new techniques

Required Qualifications and Experience

• Minimum MS in Statistics, Biostatistics, or related field (eg., Epidemiology)
• 3+ years (MS) or 1+ years (PhD) of progressive and relevant experience
• Working knowledge of CRF and database development, including attribute assignment and logic checking.
• Advanced knowledge of statistical software packages such as SAS, JMP or R.
• Knowledge of FDA regulatory requirements for IDE, BLA, PMA and 510K 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.

The annualized base salary range for this hourly role is $102,500 to $160,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Why Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.