Onsite Lead Biostatistician, IVD – Clinical Trials

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

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