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.
Primary Function of Position
As a lead biostatistician of Clinical Affairs, this role is primary responsible for developing and executing strategic and tactical framework for Clinical Affairs global evidence initiatives. The role will be responsible for leading statistical design of clinical studies and the analysis strategy in 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 studies in support of Inutitive's clnical development.
As a lead biostatistician, this role is also responsible for developing biostats function and provide guidance to other biostats team members to interface and support clinical study and other sicnetifice evidence generation requirements with applicable guidelines and regulations.
Roles and Responsibilities
* Lead strategic and tactical role in the development of Intuitive sponsored clinical studies globally
* Responsible for providing statistical guidance and expertise for clinical studies (pre market and post market ) across various Intuitive technologies, including study design, analysis, interpretation, clinical study report and manuscript development.
* Act as a key strategic partner to develop evidence generation strategy across surgical specialities and Intuitive technologies
* Lead additional research projects to generate clinical evidence, such as data analysis of large clinical databases, systematic literature reviews and meta analysis, etc
* Responsible for developing Statistical Analysis Plan, designing shells for tables, listings and fitures; developing programming specificatons for statistical analysis
* Responsible for providing statistical expertise for addressing regulatory authority questions related to statistical design and analysis for all pre-market clinical studies and post market studies/ post-market clinical follow up studies which are overseen by regulatory authories
* 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 teams, collaborate with other team members for the development of Clinical Investigational Plan, Clinical Study Report, Case Report Form and other key study documents
* 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
* Build strong relationships with study investigators and key opinion leaders to identify the publication needs; work closely with internal/external authors to develop manuscript, abstract/presentation or poster, and provide statistical support throughout the publication process
* Stay abreast of latest industry and academic developments in Statistics and modeling techniques and apply adapting methodology to solve unique or challenging study design and statistical analysis issues
* Responsible for managing resource (internal and external) and budget related to statistical analysis to ensure study success
* Provide leadership and ongoing guidance for team members to achieve high performance; effectively distills complexity and provides clear and actionable direction and information, help team prioritize, solve complex problems that enable the team to make significant progress
* 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 initatives
Competency Requirements: (Competency is based on: education, training, skills and experience.)In order to adequately perform the responsibilities of this position the individual must have:
* Advanced degree in Biostatistics or Statistics (Master or Ph. D) with sound knowledge of theretical and applied statistics
* A minimum of 5-8 years of clinical research biostats working experience in biotech industry (medical device company experience is preferred)
* People management or mentoring experience with direct or indirect reports is desirable
* Extensive experience in the development of Statistical Analysis Plan for regulatory submission, with strong capability to interact effectively with regulatory agency to address statistical questions related to study design and/or analysis
* Prove track record of success in designing a wide range of clinical studies with various statistical methodology; experience in adaptive design (e.g., sampe size re-estimation, Bayesian adaptive design) and using historical control is preferred
* In-depth knowledge and extensive experience of conducting statistical analysis to support the development of clinical study report and pubications, with strong sceitific writing and editing skills
* Proficient in R and/or SAS programming and/or a suitable statistical programming environment
* Be clinically savy and be able to bridge analytics to clinical interpretation and explain complex mathematical/statistical problems to team members and senior leadership
* Experience for analysis of a large dataset (administrative or commercial data sets) is desirable
* Strong knowledge of 21 CFR part 812 , Good Clinical Practice, ISO14155 and other regulations/guidelines on clinical research
* Excellent verbal/written communication, presentation, teamwork and interpersonal skills; capability to builid strong cross-functional collaboration both internally and externally
* High attention to detail and scientific integrity
* Excellent organizational planning, project management and time management skills
* Results-driven attitude and strong problem solving skills, consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary; demonstrated ability to adapt and adjust to changing priorities and deal with uncertainty and risks
* Must be able to travel up to 10%
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.
* Shift : * Shift 1 - Day
* Travel : * Yes, 10 % of the Time
Travel Requirements:Yes, 10 % of the Time Shift:Shift 1 - Day