Primary Function of Position:

As a member of Clinical Affairs department, the Statistical Programmer III will provide support to the analysis and reporting of clinical studies in IDE and post market evidence generation studies. The Statistical Programmer III works as a member of a cross-functional team and continuously strives to ensure timely delivery and scientific validity of results. The person will work closely with the biostatisticians, study managers, data managers, and others within the company to ensure seamless, accurate, and timely delivery of data analysis results.

The Statistical Programmer III will be tasked to assist in the development of statistical analysis plans, tables, figures, and listings, and programmatically generate analysis of various datasets to meet Intuitive Surgical regulatory submissions and scientific publication needs. The Statistical Programmer III is expected to contribute to procedure development. 

Roles & Responsibilities:

• Assist biostatisticians with preparation of SAP, tables, figures, and listings for regulatory submission, scientific publication, and other needs.
• Generate outputs programmatically for statistical analyses and share with study teams.
• Collaborate with data management and study teams on CRF, specifications, formatting, cleaning, queries, analysis, and presentation.
• Assist internal colleagues for the appropriate sections of the clinical report and the relevant supplements/amendments and responses to FDA questions, or any external/internal auditing group.
• Code SAS utility macros, implement test plans to support SAS macro development.
• Use and implement sound and appropriate best practices in coding and techniques.
• Understand and follow regulations of FDA and other regulatory authorities.
• Interact and communicate the output of the statistical analysis to study teams.
• Develop and implement SOPs, WIs, and procedures to meet regulatory and company requirements.
• Comfortable with scientific literature, read, interpret, and explain.
• Conducts all job duties in compliance of Good Clinical Practice (GCP), 21CFR and according to company SOPs and applicable FDA/ICH/EMEA guidelines.

Skills, Experience, Education, & Training:

• Minimum degree in Biostatistics or Statistics or Computer Science; Either a MS with a minimum of 3 years or a BS with a minimum of 5 years of experience in statistical programming, preferably in pharmaceutical or medical /surgical device industry.
• Core competencies of this position include a thorough working knowledge and experience in the field of SAS programming to analyze clinical data.
• Candidate must be able to work self-sufficiently with some supervision.
• Must have good organizational skills and be able to handle multiple projects simultaneously.
• Must be proficient in SAS programming or a suitable statistical programming environment.
• Have ability to understand, interpret, and communicate requirements, logics, and results.
• Application experience in surgical clinical research a plus.
• Position may require around 10% travel.
• Ability to multi-task and interact with team members who are working under deadlines.
• Ability to set priorities and excellent organizational planning, project management and time management skills.
• Attention to detail and accuracy of reporting results.
• Must have excellent verbal/written communication, teamwork, and interpersonal skills to work across multiple constituents.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.