SAS Statistical Programmer 3

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

The Statistical Programmer3 is responsible for leading the development and validation of analysis datasets, tables, figures, and listings, ensuring outputs meet high-quality standards. Additionally, this role manages multiple project timelines, collaborates with Clinical Affairs to align database design with analysis needs, and provides ad-hoc reports. This is a hybrid role requiring onsite presence in San Diego, CA, at least 3 days per week.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• 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.

Qualifications

Education and Experience

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.

Skills

• Advanced knowledge of SAS; experience with statistical software packages such as R or Python.


• Problem-solving mindset.


• 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.

The annualized base salary range for this role is $102,500 - $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.