Senior Manager Biostatistics

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 Senior Manager of Biostats in the Clinical Affairs department, this role is primary responsible for leading with statistical design and analysis strategy for clinical investigations support of regulatory submissions, evidence generation and scientific publication efforts. This position will partner with key internal and external stakeholders to design, analyze, and interpret clinical investigations in support of Intuitive's clinical development.

As a people leader, this role is also responsible for developing and managing the biostats team to interface and support multiple clinical investigations and other scientific evidence generation projects while following all applicable guidelines and regulations. Will manage and support all clinical affairs operations regarding all biostatistical needs along with some statistical support for other groups such as engineering or other research projects.

Essential Job Duties

 (Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager)

• Play a strategic role in the development of Intuitive sponsored clinical investigations globally
• Responsible for providing statistical support for clinical investigations in study design, analysis, interpretation and publication of clinical investigations
• Responsible for managing the development of Statistical Analysis Plan, designing shells for tables, listings and figures and developing programming specifications for statistical analysis for clinical investigations.
• Responsible for addressing regulatory authority questions related to statistical design and analysis for all pre-approval clinical investigations and post approval studies or post-market clinical follow up studies which are overseen by regulatory authorities
• Responsible for conducting data analysis to support the development of clinical study report, clinical evaluation report, conference or journal publications, and other regulatory submission as needed
• Represent the Biostatistics function within the cross-functional study team, collaborate with other team members for the development of Clinical Investigational Plan, Clinical Study Report, Case Report Form and other key study documents

• Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US FDA regulations and guidelines, ISO14155) and responsible for ongoing review of departmental procedures and process improvement initiatives
• Develop long range plans regarding development of biostats to meet current and future needs

Required Skills and Experience (Specific skills, knowledge, and experience that an individual must possess in order to successfully perform in job)

• Work closely with Data management to define edit specifications and critical variable lists, support data cleaning activities to ensure collection of high-quality data; handles database lock and unblinding process per study requirements
• Work closely with internal/external authors to assist development of manuscript, abstract/presentation or poster, and provide statistical support throughout the publication process
• Act as a key strategic partner to develop