Senior Biostatistician

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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 theirmost 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 Sr Biostatistician of Clinical Affairs, this role is primary responsible for developing and executing strategic and tactical frameworks 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 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 Intuitive’s clinical evidence development.

As a Sr Biostatistician, this role is also responsible for developing the biostatistics function in EMEA and to provide guidance to other team members, to support clinical studies and other scientific evidence generation requirements, apply best and current practice and meet guidelines and regulations.

This position will report to Clinical Affairs, Europe, Intuitive Surgical Headquarters, in Switzerland.

Roles And Responsibilities

• Support the development of Intuitive sponsored clinical studies in EMEA.
• Providing statistical guidance and expertise for clinical studies (pre market and post market) across various Intuitive technologies, including study design, analysis, interpretation, clinical study reports and manuscript development.
• Act as a key strategic partner to develop evidence generation strategy across surgical specialties and Intuitive technologies.
• Support 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 Plans, designing shells for tables, listings and figures; developing programming specifications for statistical analysis.
• 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 authorities.
• 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 EMEA clinical affairs Biostatistics function within 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.
• Supports the EMEA CA team working with study investigators and key opinion leaders to identify the publication needs; works closely with internal/external authors to develop manuscripts, abstract/presentation or poster, and provides 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 support 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 MDR / MEDDEV, ISO14155) and responsible for ongoing review of departmental procedures and process improvement initiatives.
  

Qualifications

Required Knowledge, Skills, and Experience:

• Advanced degree in Biostatistics or Statistics (Master or Ph. D) with sound knowledge of theoretical and applied statistics
• A minimum of 5-8 years of clinical research biostats working experience in biotech industry (medical device company experience is preferred)
• Proven 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 preferred
• In-depth knowledge and extensive experience of conducting statistical analysis to support the development of clinical study report and publications, with strong scientific writing and editing skills
• Proficient in R and/or SAS programming and/or a suitable statistical programming environment
• Be clinically savvy and be able to bridge analytics to clinical interpretation and explain complex mathematical/statistical problems to team members and senior leadership
• Knowledge of applicable medical device regulations and guidelines: MEDDEV, MDR, Good Clinical Practice, ISO-14155, GDPR
• Excellent verbal/written communication, presentation, teamwork and interpersonal skills; capability to build 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%
• English language required, a second European language (French / German) is an advantage
• Experience of studies with health economic focus is an advantage
• Experience of working with CROs or external consultants is an advantage
• Experience for analysis of a large dataset (administrative or commercial data sets) is desirable
• People management or mentoring experience with direct or indirect reports is desirable
• Extensive experience in the development of Statistical Analysis Plans for regulatory submission, with strong capability to interact effectively with regulatory agency to address statistical questions related to study design and/or analysis is desirable
  

Additional Information

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.

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 : Day

Travel : 10% of the time

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