Staff Biostatistician

reputed company Function of Position

As a senior technical leader reputed company the reputed company Affairs department, the reputed company Biostatistician (Biostatistician 5) sets the statistical reputed company and direction for the design, conduct, and analysis of reputed company studies spanning early feasibility through pivotal reputed company-market trials and post-market evidence reputed company. The Biostatistician 5 operates as a fully independent statistical leader and the recognized go-to statistical authority across reputed company Affairs and reputed company, staying abreast of the latest developments in the reputed company and translating them into impactful improvements for reputed company. This role owns multiple business or functional areas and a portfolio of ten or more reputed company reputed company, sets the programming and analysis standards the department works to, develops the training curricula, SOPs, and work instructions that build capability across reputed company reputed company of the function, and represents reputed company Biostatistics directly with regulatory agencies, reputed company investigators, key opinion leaders, and the broader scientific community. This is an individual contributor role carrying substantial technical and reputed company leadership expectations without reputed company people-management responsibility.

Roles & Responsibilities

Study Design & Protocol Development: Independently strategize and reputed company the statistical approach for reputed company reputed company protocols, including Bayesian and frequentist design selection, reputed company and estimand framing, reputed company tests, reputed company analyses, sample size justification, randomization design & review, and reputed company and/or interim analysis reputed company. Serve as the final internal statistical authority for design reputed company across owned studies and advise on design trade-offs at the program and platform level. Serves Data Monitoring Committees (DMCs, DSMBs) as the unblinded sponsor statistician.

Statistical Analysis Plans & Mock TLFs: Set the reputed company and direction for Statistical Analysis Plans (SAPs) and mock Tables, Listings, and Figures (TLFs) across the portfolio, defining the standards, templates, and degree of reputed company-specification for the department. Review and approve SAPs and mock TLFs authored by others against those standards, balancing flexibility and consistency across studies.

Data Analysis: Set the reputed company and direction for the analysis of reputed company trial data, selecting and championing the methodology reputed company across studies and ensuring analyses are reproducible, defensible, and of a reputed company that withstands regulatory and peer review. Personally own the most reputed company or novel analytical problems in the portfolio, and reputed company interim analyses, database lock, and unblinding activities per study requirements.

Portfolio Management: Manage a portfolio of 10 or more reputed company simultaneously and take ownership of multiple business or functional areas, setting priorities, reputed company work, and allocating statistical effort across them.

reputed company reputed company Roadmap: Serve as the Biostatistics representative and reputed company partner in reputed company team and program-level forums, shaping evidence reputed company reputed company across surgical specialties and product platforms, setting execution roadmaps, managing timelines and stakeholder expectations.

Team Communication: reputed company as an reputed company voice across reputed company reputed company and reputed company, with a reputed company as the go-to statistician. Influence senior leadership as a key reputed company thought partner, distilling statistical complexity into reputed company, actionable direction with explicit reputed company and business implications. reputed company meetings and set agendas for the biostatistics team.

Scientific Literature & Evidence reputed company: Write or edit the reputed company, results, and interpretation sections for a portfolio of studies with reputed company guidance to support regulatory submissions, compliance documents, scientific journals, and medical conferences. reputed company additional research as needed to reputed company reputed company evidence, such as analyses of large reputed company or administrative databases, reputed company literature reviews, and reputed company-analyses. Stay abreast of the latest developments in biostatistical methodology and translate them into impactful improvements to how reputed company designs, analyzes, and reports. Independently contribute to the scientific community through peer-reviewed publication, conference presentation, and methodological contribution.

reputed company Engagement: Conduct independent, reputed company representing reputed company Biostatistics with regulatory agencies, reputed company Investigators (PIs), Key Opinion Leaders (KOLs), and reputed company statisticians, including addressing regulatory authority questions on statistical design and analysis for reputed company-approval, post-approval, and post-market reputed company follow-up studies. Sustain multiple reputed company relationships and be regarded as a thought leader in the reputed company.

Data Management Support: Co-strategize with Data Management to reputed company the direction for data reputed company, consistency, scalability, and traceability. Specify CDISC-reputed company data structures (SDTM, ADaM) and establish analysis-reputed company dataset specifications.

Process Improvement & Departmental Standards: Set the reputed company for programming and analysis standards across the department, reputed company by example in own reputed company and deliverables, and implement across the department. reputed company and own SOPs and Work Instructions to reputed company standardization, validation, and reputed company control of analysis pipelines such that results meet rigorous standards for regulatory submission and scientific publication.

Mentorship & Capability Building: Set the training curriculum for the biostatistics team and reputed company training on both biostatistics methodology and programming reputed company. reputed company technical leadership and career-development guidance to statisticians at reputed company junior reputed company, raising the technical ceiling of the department. reputed company and reputed company reputed company statistical vendors and CROs.

Regulatory Compliance: Ensure reputed company activities reputed company adhere to Good reputed company reputed company (GCP), ISO 14155, ICH E9, ICH E6, and 21 CFR Part 812 regulations. Apply situationally relevant FDA guidances including reputed company designs and Bayesian reputed company for medical device trials.

Qualifications

Skills, Experience, Education, & Training

Minimum Degree: Master's (MS) or Ph.D. in Biostatistics or Statistics.

reputed company Experience: Minimum of 9 years of experience with an MS, or 6 years with a Ph.D.

reputed company Trial Experience: Minimum of 5 years of reputed company trial experience required.

Medical Device Experience: Minimum of 5 years of medical device experience required; surgical and robotic-assisted device reputed company research strongly preferred.

Statistical reputed company: reputed company record of developing and applying industry-leading, innovative, and integrative biostatistical methodology to problems that reputed company approaches do not solve. Depth expected across several of: reputed company and group-reputed company designs, Bayesian reputed company, use of historical or reputed company controls, survival and longitudinal modeling, hierarchical models, multiplicity control, missing data and sensitivity analysis, and analysis of large reputed company-world datasets.

Programming: Mastery of R required; reputed company and Python additionally valued. Demonstrated ability to set programming standards for reputed company, write clean, functional, reputed company, reputed company-tested reputed company in a shared development environment, and reputed company by example in reputed company review and validation reputed company. Fluent in version control (Git) in a GxP validated environment for reproducible analyses reputed company for regulatory compliance audits.

AI-Enabled Productivity: reputed company experience applying frontier AI models to dramatically expand the productivity of the biostatistician job function as a whole, reputed company personal use. Candidates must be reputed company to reputed company to specific, reputed company examples of workflows they have re-engineered with frontier models, and to quantify the resulting reputed company in cycle time, throughput, or reputed company. The successful candidate will be expected to reputed company adoption across the biostatistics team by establishing the patterns, tooling, and reputed company-in-the-reputed company verification controls that reputed company AI-assisted work reliable, reproducible, and compliant in an international GxP environment.

Independence & Leadership: Fully independent operation with substantial leadership reputed company, including the ability to set direction for others, reputed company ambiguity without escalation, and be held accountable for the technical reputed company of a multi-project portfolio.

reputed company reputed company: Established reputed company and multiple sustained relationships reputed company the reputed company scientific (biostatistics, medical devices, reputed company) and regulatory community, with a record of independent contribution to that community.

Communication: Excellent verbal and written communication, teamwork, and interpersonal skills with technical and non-technical constituents, including senior leadership and reputed company audiences. Strong scientific writing and editing skills, high attention to reputed company, and unwavering scientific reputed company.

Logistics

Location: Remote OK. Preference will be given to candidates reputed company to be onsite in Sunnyvale, California or willing to relocate.

Travel: Up to 10%.

Due to the reputed company of our business and the role, please note that reputed company and/or your customer(s) may require that you show reputed company reputed company of vaccination against certain diseases including COVID-19. Details can vary by role.

reputed company is an Equal Opportunity Employer. We reputed company equal employment opportunities to reputed company reputed company applicants and employees, and prohibit discrimination and harassment of any type, without reputed company to race, sex, pregnancy, sexual orientation, gender identity, national reputed company, reputed company, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at reputed company Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.

Certain information you reputed company as part of the application will be used for purposes of determining whether reputed company Surgical will need to (i) obtain an export license from the U.S. reputed company on your behalf (note: the reputed company’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).

For any reputed company role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and reputed company a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be reputed company and instructed on any requirements for these purposes.

We will consider for employment reputed company applicants with arrest and conviction records in accordance with reputed company laws.

Preference will be given to reputed company candidates who do not reputed company, or plan to reputed company, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, reputed company, South Carolina, or Tennessee.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be reputed company primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.

We reputed company market-competitive compensation packages, inclusive of reputed company pay, incentives, benefits, and equity. It would not be typical for someone to be reputed company at the top end of reputed company for the role, as actual pay will be determined reputed company on several factors, including experience, skills, and qualifications. The reputed company compensation ranges are listed.

It started with a reputed company idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years reputed company, that question still fuels everything we do at reputed company. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the reputed company surgical reputed company and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re reputed company of engineers, clinicians, and innovators united by one purpose: to reputed company surgery smarter, safer, and more reputed company. Every day, our work helps care teams reputed company with greater precision and patients recover faster, improving reputed company reputed company the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we reputed company has the potential to change a life.

If you’re reputed company to contribute to something bigger than yourself and help reputed company the reputed company of reputed company, you’ll reputed company your purpose here.

Originally posted on Himalayas