Job Description
Details
Job Posting ID:
ISIJP00011814
Job Posting Title:
Biostatistician 4
Description:
Pay
rate for CA - $93/hr
Pay rate non-CA - $80/Hr
WOW - Preferred Onsite 3 days but Open for Remote
Primary Function of Position
As a key member of the Clinical Affairs department, the
Senior Biostatistician (Biostatistician IV) provides advanced statistical
expertise to support the design, conduct, and analysis of clinical studies,
ranging from early pre-market to post-market evidence generation. The
Biostatistician IV is the statistical subject matter expert working in
cross-functional teams, managing roadmaps and priorities to ensure timely and
high quality delivery of results. This role serves as a nearly independent
statistical lead, providing technical leadership by improving analysis
processes, mentoring junior staff, and managing a diverse project portfolio to
ensure that clinical evidence meets the highest standards for regulatory
submissions and scientific publication.
Roles & Responsibilities
Study Design & Protocol Development: Lead the writing
of statistical sections for complex clinical protocols with limited
supervision, ensuring robust study designs, hypothesis tests, power analyses,
and sample size justifications.
Data Analysis: Utilize appropriate and robust statistical
and programming methodology in the analysis of clinical trial data, including
complex and advanced methods as needed, ensuring high-quality results for
regulatory submissions and scientific publications.
Clinical Operations Roadmap: Serve as the Biostatistics
representative in core team meetings, setting functional roadmaps and managing
stakeholder expectations.
Portfolio Management: Manage a portfolio of 3–7 projects
simultaneously and take ownership of one specific business or functional area.
Team Communication: Interpret complex statistical results
for cross-functional teams in a clear and actionable manner, considering
clinical implications and proactively offering alternative solutions.
Scientific Literature and Evidence Generation:
Independently search and learn from scientific literature. Write complete
methods, results, and analysis interpretation sections with supervision for
regulatory submissions, compliance, scientific journals, and medical
conferences. Explore novel biostatistical & programming methodology
applications.
External Engagement: Engage with external stakeholders,
including regulatory agencies, Principal Investigators (PIs), and Key Opinion
Leaders (KOLs) to define requirements, generate deliverables, and gather
feedback.
Data Management Support: Partner with Data Management to
co-standardize edit specifications, critical variable lists, data structures,
and extraction workflows to ensure data integrity and scalability.
Process Improvement: Improve standardization and quality
control of analysis pipelines across projects, ensuring high-quality results
for regulatory submissions and scientific publications. Improve and implement
SOPs and WIs for Statistical Analysis Plans (SAPs) and mock Tables, Listings,
and Figures (TLFs), balancing flexibility and consistency across studies.
Mentorship: Provide guidance and leadership to junior
biostatisticians.
Regulatory Compliance: Ensure all activities strictly
adhere to Good Clinical Practice (GCP), ISO 14155, and 21 CFR Part 812
regulations.
Skills, Experience, Education, & Training Minimum
Degree: Master’s (MS) or Ph.D. in Biostatistics or Statistics.
Professional Experience: Minimum of 6 years of experience
with an MS, or 3 years with a Ph.D..
Industry Experience: Minimum of 4 years of experience in
clinical trials, surgical medical device clinical research strongly preferred.
Statistical Methods: Proven expertise in advanced and
complex statistical methodologies, including experience with adaptive designs
or Bayesian methods.
Programming: Mastery of R preferred, SAS and Python also
considered; ability to write clean, functional, modular code for a team
development environment and train junior team members in best practices.
Independence & Leadership: Demonstrated ability to
work nearly independently while providing functional mentorship to junior
biostatisticians.
External Reputation: Track record of strong professional
relationships within the external scientific (biostatistics, medical devices,
clinical trials) and/or regulatory community.
Communication: Excellent verbal and written
communication, teamwork, and interpersonal skills with both technical and
non-technical constituents.
Logistics
Location: Preference will be given to candidates able to
be onsite in Sunnyvale, California or willing to relocate.
Travel: Position may require up to 10% travel.
Job Posting Start Date:
04/01/2026
Job Posting End Date:
03/31/2027
Business Unit:
Clinical Public Affairs Function
Site:
1020 Kifer
Rd, Bldg 108
Location:
Sunnyvale
Requirements
Senior Biostatistician (Biostatistician IV)
Pay rate for CA
- $93/hr
Pay rate non-CA
- $80/Hr
Location:
Preference will be given to
candidates able to be on site in Sunnyvale,
California or willing to
relocate.
Travel:
Position may require up to 10% travel.
WOW - Preferred Onsite 3 days but Open for
Remote
Primary Function of Position
As a key member of the Clinical Affairs department, the Senior Biostatistician
(Biostatistician IV) provides advanced statistical expertise to support the
design, conduct, and analysis of clinical studies, ranging from early
pre-market to post-market evidence generation. The Biostatistician IV is the
statistical subject matter expert working in cross-functional teams, managing
roadmaps and priorities to ensure timely and high quality delivery of results.
This role serves as a nearly independent statistical lead, providing technical
leadership by improving analysis processes, mentoring junior staff, and
managing a diverse project portfolio to ensure that clinical evidence meets the
highest standards for regulatory submissions and scientific publication.
Roles & Responsibilities
Study Design & Protocol Development: Lead the writing of statistical
sections for complex clinical protocols with limited supervision, ensuring
robust study designs, hypothesis tests, power analyses, and sample size
justifications.
Data Analysis:
Utilize appropriate and robust statistical and
programming methodology in the analysis of clinical trial data, including
complex and advanced methods as needed, ensuring high-quality results for
regulatory submissions and scientific publications.
Clinical Operations Roadmap: Serve as the Biostatistics representative in core
team meetings, setting functional roadmaps and managing stakeholder
expectations.
Portfolio Management:
Manage a portfolio of 3–7 projects simultaneously
and take ownership of one specific business or functional area.
Team Communication:
Interpret complex statistical results for
cross-functional teams in a clear and actionable manner, considering clinical
implications and proactively offering alternative solutions.
Scientific Literature and Evidence Generation:
Independently search and
learn from scientific literature. Write complete methods, results, and analysis
interpretation sections with supervision for regulatory submissions,
compliance, scientific journals, and medical conferences. Explore novel
biostatistical & programming methodology applications.
External Engagement:
Engage with external stakeholders, including
regulatory agencies, Principal Investigators (PIs), and Key Opinion Leaders
(KOLs) to define requirements, generate deliverables, and gather feedback.
Data Management Support:
Partner with Data Management to co-standardize
edit specifications, critical variable lists, data structures, and extraction
workflows to ensure data integrity and scalability.
Process Improvement:
Improve standardization and quality control of
analysis pipelines across projects, ensuring high-quality results for
regulatory submissions and scientific publications. Improve and implement SOPs
and WIs for Statistical Analysis Plans (SAPs) and mock Tables, Listings, and
Figures (TLFs), balancing flexibility and consistency across studies.
Mentorship:
Provide guidance and leadership to junior biostatisticians.
Regulatory Compliance:
Ensure all activities strictly adhere to Good
Clinical Practice (GCP), ISO 14155, and 21 CFR Part 812 regulations.
Skills, Experience, Education, & Training
Minimum Degree:
Master’s (MS) or Ph.D. in Biostatistics or
Statistics.
Professional Experience: Minimum of 6 years of experience with an MS, or 3
years with a Ph.D..
Industry Experience: Minimum of 4 years of experience in clinical trials,
surgical medical device clinical research strongly preferred.
Statistical Methods: Proven expertise in advanced and complex statistical
methodologies, including experience with adaptive designs or Bayesian methods.
Programming: Mastery of R preferred, SAS and Python also considered; ability to
write clean, functional, modular code for a team development environment and
train junior team members in best practices.
Independence & Leadership: Demonstrated ability to work nearly
independently while providing functional mentorship to junior biostatisticians.
External Reputation: Track record of strong professional relationships within
the external scientific (biostatistics, medical devices, clinical trials)
and/or regulatory community.
Communication: Excellent verbal and written communication, teamwork, and
interpersonal skills with both technical and non-technical constituents.
Logistics