Lead Biostatistician
Company: Intuitive
Location: Sunnyvale
Posted on: June 17, 2022
Job Description:
Company DescriptionAt Intuitive, we are united behind our
mission: we believe that minimally invasive care is life-enhancing
care. Through ingenuity and intelligent technology, we expand the
potential of physicians to heal without constraints.As a pioneer
and market leader in robotic-assisted surgery, we strive to foster
an inclusive and diverse team, committed to making a difference.
For more than 25 years, we have worked with hospitals and care
teams around the world to help solve some of healthcare's hardest
challenges and advance what is possible.Intuitive has been built by
the efforts of great people from diverse backgrounds. We believe
great ideas can come from anywhere-we strive to foster an inclusive
culture built around diversity of thought and mutual respect. We
lead with inclusion and empower our team members to do their best
work as their most authentic selves.Passionate people who want to
make a difference drive our culture-our team members are grounded
in integrity, have a strong capacity to learn, the energy to get
things done, and bring diverse, real world experiences to help us
think in new ways. We actively invest in our team members to
support their long-term growth so they can continue to advance our
mission and achieve their highest potential.Join a team committed
to taking big leaps forward for a global community of healthcare
professionals and their patients. Together, let's advance the world
of minimally invasive care.Job DescriptionPrimary Function of
Position:As a lead biostatistician of Clinical Affairs, this role
is primary responsible for developing - and executing - strategic
and tactical framework for Clinical Affairs global evidence
initiatives. The role will be responsible for leading - statistical
design of clinical studies and the analysis 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 Inutitive's clnical development.As a
lead biostatistician, -this role is also responsible for developing
biostats function and provide guidance to other biostats team
members to interface and support clinical study and other
sicnetifice evidence generation requirements with applicable
guidelines and regulations. -Roles and Responsibilities:
- Lead strategic and tactical role in the development of
Intuitive sponsored clinical studies globally
- Responsible for providing statistical guidance and expertise -
for clinical studies - (pre market and post market ) across various
Intuitive technologies, including study design, analysis,
interpretation, clinical study report and manuscript
development.
- Act as a key strategic partner to develop evidence generation
strategy across surgical specialities and Intuitive
technologies
- Lead additional research projects to generate clinical
evidence, such as data analysis of large clinical databases,
systematic literature reviews and meta analysis, etc
- Responsible for developing Statistical Analysis Plan, designing
shells for tables, listings and fitures; developing programming
specificatons for statistical analysis
- Responsible for providing statistical expertise - for
addressing regulatory authority questions related to statistical
design and analysis for all pre-market clinical studies and post
market -studies/ post-market clinical follow up studies which are
overseen by regulatory authories
- 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
cross-functional teams, collaborate 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 strong 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
- 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
- Responsible for managing resource (internal and external) and
budget related to statistical analysis to ensure study
success
- Provide leadership and ongoing guidance for team members to
achieve high 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
- 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
initatives.QualificationsSkill/Job Requirements:Competency
Requirements: (Competency is based on: education, training, skills
and experience.)In order to adequately perform the responsibilities
of this position the individual must have:
- Advanced degree in Biostatistics or Statistics (Master or Ph.
D) with sound knowledge of theretical and applied
statistics
- A minimum of 5-8 years of clinical research biostats working
experience in biotech industry (medical device company experience
is preferred)
- People management or mentoring experience with direct or
indirect reports is desirable
- Extensive experience in the development of Statistical Analysis
Plan for regulatory submission, with strong capability to interact
effectively with regulatory agency to address statistical questions
related to study design and/or analysis
- Prove track record of success in designing a wide range of
clinical studies with various statistical methodology; experience
in adaptive design (e.g., sampe size re-estimation, Bayesian
adaptive design) and using historical control is preferred
- In-depth knowledge and extensive experience of conducting
statistical analysis to support the development of clinical study
report and pubications, with strong sceitific writing and editing
skills
- Proficient in R and/or SAS programming and/or a suitable
statistical programming environment
- Be clinically savy and be able to bridge analytics to clinical
interpretation and explain complex mathematical/statistical
problems to team members and senior leadership
- Experience for analysis of a large dataset (administrative or
commercial data sets) is desirable
- 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 builid strong
cross-functional collaboration both internally and
externally
- High attention to detail and scientific integrity
- Excellent organizational planning, project management and time
management skills
- Results-driven attitude and strong problem solving skills,
consistently shows dedication or strong work-ethic to help meet
aggressive timelines or multiple projects when necessary;
demonstrated ability to adapt and adjust to changing priorities and
deal with uncertainty and risks
- Must be able to travel up to 10%
- 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
COVID-19. - 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.#911Additional InformationAll your information will be kept
confidential according to EEO guidelines.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 COVID-19. - 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. Shift : Day
Travel : 10% of the timeTravel Requirements:10% of the time
Shift:Day
Keywords: Intuitive, Sunnyvale , Lead Biostatistician, Other , Sunnyvale, California
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