Manager Biostatistics

Company DescriptionAt 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 DescriptionPrimary Function of Position : As a functional manager of Biostats in Clinical Affairs, this role is primary responsible for leading statistical design of clinical studies and the research 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 people manager, this role is also responsible for developing and managing the biostats team to interface and support clinical study and other scientific evidence generation requirements with applicable guidelines and regulations.Roles & Responsibilities : Play a strategic role in the development of Intuitive sponsored clinical studies globallyResponsible for providing statistical support for clinical studies in study design, analysis, interpretation and publication of clinical studiesResponsible for developing Statistical Analysis Plan, designing shells for tables, listings and figures; developing programming specifications for statistical analysisResponsible for addressing regulatory authority questions related to statistical design and investigation for all pre-approval clinical studies and post approval studies or post-market clinical follow up studies which are overseen by regulatory authoritiesResponsible for conducting data analysis to support the development of clinical study report, clinical evaluation report, conference or journal publications, and other regulatory submission as neededRepresent the Biostatistics function within the cross-functional study team, partner with other team members for the development of Clinical Investigational Plan, Clinical Study Report, Case Report Form and other key study documentsWork 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 requirementsBuild effective 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 processAct as a key strategic partner to develop evidence generation strategy across surgical specialties and product platformsManage additional research projects to generate clinical evidence, such as data analysis of large clinical databases, systematic literature reviews and meta-analysis, etc.Stay abreast of latest industry and academic developments in Statistics and modeling techniques and apply adaptive methodology to solve unique or challenging study design and statistical analysis issuesResponsible for managing resource (internal and external) and budget related to statistical analysis to ensure study successProvide functional manager leadership to direct reports and provide ongoing guidance for the assigned team members in their internal / external communication and support direct reports in consistently achieving their goals and prioritiesSets and holds individual and team accountable for high standard of competencies and overall performanceEffectively distills complexity and provides clear and actionable direction and information, help team prioritize, solve complex problems that enable the team to make significant progressDevelop talents, build a highly capable and effective biostats team within the organizationEnsure 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 initiativesQualificationsSkills, Experience, Education, & Training : Advanced degree in Biostatistics or Statistics (Masters or Ph. D) with sound knowledge of theoretical and applied statisticsA minimum of 8 years of biotech industry clinical research experience (medical device company experience preferred)A minimum of 3 years of people management experience with direct reports; experience building a biostats team over time is desirableProve track record of success in designing a wide range of clinical studies with various statistical methodology; experience in adaptive design (e.g., sample size re-estimation, Bayesian adaptive design) and using historical control is preferredExtensive experience in the development of Statistical Analysis Plan for regulatory submissionProven capability to interact effectively with regulatory agency to address statistical questions related to study design and / or investigationIn-depth knowledge and extensive experience of conducting statistical analysis to support the development of clinical study report and publications, with effective scientific writing and editing skillsProficient in R and / or SAS programming and / or a suitable statistical programming environmentBe clinically savvy and be able to bridge analytics to clinical interpretation and explain complex mathematical / statistical problems to team members and senior leadershipExperience for examination of a large dataset (administrative or commercial data sets) is desirableProven knowledge of 21 CFR part 812, Good Clinical Practice, ISO14155 and other regulations / guidelines on clinical researchExcellent verbal / written communication, presentation, teamwork and relational skills; capability to build effective cross-functional coordination both internally and externallyHigh attention to detail and scientific integrityExcellent organizational planning, project management and time management skillsResults-driven attitude and effective problem solving skills, consistently shows dedication or excellent work-ethic to help meet timelines or multiple projects when necessary; demonstrated ability to adjust to changing priorities and deal with uncertainty and risksAdditional InformationDue 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.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.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 / Affirmative Action 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.EEO and AA PolicyWe 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.SummaryType : Full-timeFunction : OtherExperience level : Mid-Senior LevelIndustry : Medical Device