Hybrid SAS Programmer III - Lead Analytics

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

Job summary

Join Hologic, Inc. in San Diego for a Statistical Programmer3 role that leads development and validation of analysis datasets, tables, figures, and listings, aligning databases with analysis needs and providing ad-hoc reports.

This hybrid position demands onsite presence in San Diego, CA, at least 3 days per week and collaboration with Clinical Affairs to ensure regulatory and data standards are met. The incumbent will manage multiple project timelines, supervise junior staff, review study

Qualifications

• Bachelor's degree in Statistics, Epidemiology, or a related quantitative discipline and 5+ years of progressive, relevant experience; or Master's degree in a related field and 3+ years of progressive, relevant experience.
• Advanced knowledge of SAS; experience with statistical software packages such as R or Python.
• Working knowledge of CRF and database structure, including attribute assignment and logic checking.
• Knowledge of FDA regulatory requirements for IDE, BLA, PMA and 510K submissions; also, GCP and ICH guidelines.
• Knowledge of infectious disease, cancer, genomics, and common public health issues.
• Experience in technical writing.
• Working knowledge of basic statistics. Capable of implementing these ideas in clear, efficient code for data analysis and reporting.

Responsibilities

• Develops and validates programs that generate analysis datasets, tables, figures, and listings as specified in the statistical analysis plan and programming specifications.
• Works to ensure that outputs meet quality standards and project requirements.
• Keeps project team members informed of programming progress and issues requiring their attention.
• Works with other projects team members in Clinical Affairs to ensure CRF and database design meets analysis needs.
• Provides ad-hoc requests and reports to help monitor trial progression and meet project team needs.
• Manages scheduling and time constraints across multiple projects and adapts to timeline or priority changes by reorganizing daily workload.
• Maintains expertise in current programming techniques and actively learns new techniques.
• Review and approve study specific documents.
• Provides input on Data Management SOPs and Statistical Programming SOPs and work instructions. Recommends and implements continuous process improvement ideas.
• Develops and maintains programming specifications according to the statistical analysis plan.
• Assists in training and mentoring new or junior team members.

Skills

Problem-solving mindset

CRF and database structure knowledge

FDA regulatory knowledge (IDE, BLA, PM

GCP and ICH guidelines

Infectious disease, cancer, genomics

Technical writing

Basic statistics

Education

Bachelor's degree in Statistics or related quantitative discipline

Master's degree in related field

Tools

SAS

R

Python

Job description

Join Hologic, Inc. in San Diego for a Statistical Programmer3 role that leads development and validation of analysis datasets, tables, figures, and listings, aligning databases with analysis needs and providing ad-hoc reports.

This hybrid position demands onsite presence in San Diego, CA, at least 3 days per week and collaboration with Clinical Affairs to ensure regulatory and data standards are met. The incumbent will manage multiple project timelines, supervise junior staff, review study