Manager Biostatistics

Primary 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 Inutitives 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 globally
• Responsible for providing statistical support for clinical studies in study design analysis interpretation and publication of clinical studies
• Responsible for developing Statistical Analysis Plan designing shells for tables listings and figures; developing programming specifications for statistical analysis
• Responsible for addressing regulatory authority questions related to statistical design and investigation for all preapproval clinical studies and post approval studies or postmarket 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 crossfunctional study team partner 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 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 process
• Act as a key strategic partner to develop evidence generation strategy across surgical specialties and product platforms
• Manage additional research projects to generate clinical evidence such as data analysis of large clinical databases systematic literature reviews and metaanalysis 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 issues
• Responsible for managing resource (internal and external) and budget related to statistical analysis to ensure study success
• Provide 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 priorities
• Sets and holds individual and team accountable for high standard of competencies and overall 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
• Develop talents build a highly capable and effective biostats team within the organization
• Ensure compliance with corporate (e.g. SOPs) 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

Qualifications :

Skills Experience Education & Training:

• Advanced degree in Biostatistics or Statistics (Masters or Ph. D) with sound knowledge of theoretical and applied statistics
• A 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 desirable
• Prove track record of success in designing a wide range of clinical studies with various statistical methodology; experience in adaptive design (e.g. sample size reestimation Bayesian adaptive design) and using historical control is preferred
• Extensive experience in the development of Statistical Analysis Plan for regulatory submission
• Proven capability to interact effectively with regulatory agency to address statistical questions related to study design and/or investigation
• Indepth knowledge and extensive experience of conducting statistical analysis to support the development of clinical study report and publications with effective 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
• Experience for examination of a large dataset (administrative or commercial data sets) is desirable
• Proven knowledge of 21 CFR part 812 Good Clinical Practice ISO14155 and other regulations/guidelines on clinical research
• Excellent verbal/written communication presentation teamwork and relational skills; capability to build effective crossfunctional coordination both internally and externally
• High attention to detail and scientific integrity
• Excellent organizational planning project management and time management skills
• Resultsdriven attitude and effective problem solving skills consistently shows dedication or excellent workethic to help meet timelines or multiple projects when necessary; demonstrated ability to adjust to changing priorities and deal with uncertainty and risks

Additional Information :

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 COVID19. 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 marketcompetitive 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 COVID19.  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 Policy

We 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 marketcompetitive 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.

Remote Work :

No

Employment Type :

Fulltime