Sr. Manager, Biostatistics
Company: Disability Solutions
Location: San Diego
Posted on: May 7, 2024
Job Description:
Working with UsChallenging. Meaningful. Life-changing. Those
aren't words that are usually associated with a job. But working at
Bristol Myers Squibb is anything but usual. Here, uniquely
interesting work happens every day, in every department. From
optimizing a production line to the latest breakthroughs in cell
therapy, this is work that transforms the lives of patients, and
the careers of those who do it. You'll get the chance to grow and
thrive through opportunities uncommon in scale and scope, alongside
high-achieving teams rich in diversity. Take your career farther
than you thought possible.Bristol Myers Squibb recognizes the
importance of balance and flexibility in our work environment. We
offer a wide variety of competitive benefits, services and programs
that provide our employees with the resources to pursue their
goals, both at work and in their personal lives. Read more:
careers.bms.com/working-with-us .Position Summary The
biostatistician is a member of cross-functional development teams
and contributes to trial design, protocol development, analysis
planning, interpretation of results, and preparation of regulatory
submissions. With appropriate experience, biostatisticians can have
responsibilities for integrated summaries and/or supporting a
particular indication of an asset. These individuals develop
collaborative relationships and work effectively with the GBS
Biostatistics Lead, the GBS Planning and Execution Lead, medical
monitor, protocol manager, data manager, PK scientist, and other
members of the study/indication team. Biostatisticians are
individual contributors and report to a GBS Lead.Position
Responsibilities
- Develops expertise beyond biostatistics by researching the
medical literature and regulatory documents to develop an
understanding of the clinical, regulatory and commercial
climate.
- Contributes to preparation of the development strategy that
will allow for effective and safe utilization of the product.
- Drives the design of innovative and efficient clinical trials,
including the selection of populations to study and endpoints to
use. Develop designs that address study objectives that will
support regulatory approval and market access.
- Translates scientific questions into statistical terms and
statistical concepts into layman terms.
- Challenges collaborator assumptions and positions based on
facts and provide insights and perspective based on available
information.
- Ensures that all analyses conducted have clearly articulated
hypotheses associated with them and that the trial design and data
collected support conducting the analysis.
- Communicates effectively with clinical and regulatory partners
and external opinion leaders.
- Builds the external reputation of BMS R&D via external
interactions through collaborations with alliance partners,
academic and government research organizations and through
conference participation.
- Authors and/or reviews protocol synopsis, protocol, statistical
analysis plan, data presentation plan, case-report forms, clinical
study reports, associated publications and other study level
specification documents.
- Exercises cost-disciplined science in sizing of the trials and
in the planning for the analyses to be conducted.
- Compliant with BMS processes and SOPs, global and project
standards, and responsible for quality of deliverables.
- Ensures programming team or vendor partner understands the
nature of the clinical data being collected and the approaches to
summarizing the information.
- Collaborates with clinicians and medical writers to prepare
summaries of results for use in regulatory documents and scientific
articles.
- Drives, with the Clinician, the interpretation of results,
development of key messages and communication to the development
team.
- Drives alignment at team (IPT) level, and escalates lack of
team alignment to the GBDS Lead for resolution.
- Provides statistical consultation for ad hoc analysis requests
including design of appropriate analyses to answer relevant
questions.
- Takes accountability for ensuring quality in all planning,
design and execution of assignments associated with the assigned
protocol or project.
- Keeps up-to-date with state-of-the art applied statistical
methodology.
- Degree RequirementsSignificant academic training in statistics,
biostatistics or relevant areas of study. PhD degree in statistics
or biostatistics or Master's degree with relevant experience
required.Experience Requirements> 3 years Pharmaceutical/R&D
or other related experienceKey Competency Requirements
- Understanding of the application of biostatistics to
medical/clinical trials data.
- Ability to work successfully within cross-functional teams
leading to successful global regulatory filings and approvals.
- Excellent verbal and written communications skills.
- Ability to be flexible and adapt quickly to the changing needs
of the organization.
- Ability to organize multiplework assignments and establish
priorities.
- Strong interpersonal skills evidenced in interactions with
individuals at all levels of the organization, and demonstrated
ability to develop relationships within the organization and
leverage the formal and informal organizational structure to assist
in goal achievement. If you come across a role that intrigues you
but doesn't perfectly line up with your resume, we encourage you to
apply anyway. You could be one step away from work that will
transform your life and career. Uniquely Interesting Work,
Life-changing CareersWith a single vision as inspiring as
Transforming patients' lives through science--- , every BMS
employee plays an integral role in work that goes far beyond
ordinary. Each of us is empowered to apply our individual talents
and unique perspectives in an inclusive culture, promoting
diversity in clinical trials, while our shared values of passion,
innovation, urgency, accountability, inclusion and integrity bring
out the highest potential of each of our colleagues.On-site
Protocol BMS has a diverse occupancy structure that determines
where an employee is required to conduct their work. This structure
includes site-essential, site-by-design, field-based and
remote-by-design jobs. The occupancy type that you are assigned is
determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned
facility. Site-by-design roles may be eligible for a hybrid work
model with at least 50% onsite at your assigned facility. For these
roles, onsite presence is considered an essential job function and
is critical to collaboration, innovation, productivity, and a
positive Company culture. For field-based and remote-by-design
roles the ability to physically travel to visit customers, patients
or business partners and to attend meetings on behalf of BMS as
directed is an essential job function. BMS is dedicated to ensuring
that people with disabilities can excel through a transparent
recruitment process, reasonable workplace
accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace
accommodation/adjustment prior to accepting a job offer. If you
require reasonable accommodations/adjustments in completing this
application, or in any part of the recruitment process, direct your
inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/
eeo -accessibility to access our complete Equal Employment
Opportunity statement. BMS cares about your well-being and the
well-being of our staff, customers, patients, and communities. As a
result, the Company strongly recommends that all employees be fully
vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest
and conviction records, pursuant to applicable laws in your
area.Any data processed in connection with role applications will
be treated in accordance with applicable data privacy policies and
regulations.
Keywords: Disability Solutions, Cathedral City , Sr. Manager, Biostatistics, Executive , San Diego, California
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