Senior Manager Biostatistics

Intuitive • Sunnyvale, CA

255d • $184,400 - $276,600 • Onsite

About The Position

As a Senior Manager of Biostats in the Clinical Affairs department, this role is primarily 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 Intuitive's 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.

Requirements

• 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.
• A minimum of 3-5 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 cross-functional collaboration both internally and externally.

Nice To Haves

• 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 re-estimation, Bayesian adaptive design) and using historical control is preferred.
• Clinically savvy and 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.

Responsibilities

• Play a strategic role in the development of Intuitive sponsored clinical investigations globally.
• Provide statistical support for clinical investigations in study design, analysis, interpretation and publication of clinical investigations.
• Manage the development of Statistical Analysis Plan, designing shells for tables, listings and figures and developing programming specifications for statistical analysis for clinical investigations.
• Address regulatory authority questions related to statistical design and analysis for all pre-approval clinical investigations and post approval studies or post-market clinical follow up studies which are overseen by regulatory authorities.
• Conduct 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 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., 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 initiatives.
• Develop long range plans regarding development of biostats to meet current and future needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Master's degree