Statistical Programmer 3

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

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.

Qualifications

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 excelle