Senior Manager Biostatistics
Senior Manager Biostatistics
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Salary Not Disclosed
1 Vacancy
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 Intuitives 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 preapproval clinical investigations 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 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. 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
- 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 highquality 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 evidence generation strategy across surgical specialties and product platforms
- Lead 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 adapting methodology to solve unique or challenging study design and statistical analysis issues
- 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 objectives
- Effectively distills complexity and provides clear and actionable direction and information help team prioritize solve complex problems that enable the team to make significant
- A minimum of 35 years of people management experience with direct reports; experience building a biostats team over time is desirable
- Proficient in R and/or SAS programming and/or a suitable statistical programming environment
- 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 build strong crossfunctional collaboration both internally and externally
Qualifications :
Required Education and Training
(As applicable Specific education and training that an individual must possess in order to successfully perform in job)
- Minimum of 10 years of biostats clinical research experience working in a medical device or related industry.
- Advanced degree in Biostatistics or Statistics (Masters or Ph. D) with sound knowledge of theoretical and applied statistics
Working Conditions
- None
Preferred Skills and Experience
- Proven track record of success in designing a wide range of clinical investigations using various statistical methodology; experience in adaptive design (e.g. sample size reestimation Bayesian adaptive design) and using historical control is preferred
- Clinically savvy and be able to bridge analytics to clinical interpretation and explain complex mathematical/statistical problems to team members and senior leadership
- Experience with analyses of a large dataset (administrative or commercial data sets) is desirable
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 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.
Mandatory Notices
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
Employment Type
Full-time
