Biostatistician
Company: Brii Biosciences
Location: San Mateo
Posted on: June 20, 2022
Job Description:
SUMMARY: The Biostatistician will serve as statistical lead for
designed clinical program, providing statistical expertise to
multiple studies, addressing statistical issues arising in
regulatory settings, and overseeing CRO statistical/programming
activities.DUTIES AND RESPONSIBILITIES:
- Act as the matter for expert in biostatistics, advising company
senior management, medical and clinical operations teams on the
most up-to-date biostatistics methodology and tools in drug
development.
- Work as a core member in clinical development team,
contribution to design a clinical study protocol that is clinical
sound and statistically efficient.
- Provide support to the clinical study team on data and
biostatistics related issued and/or questions.
- Ensure the statistical analysis and the submission datasets
meet the regulatory requirements.
- Represent the company as Biostatistics expert in the
communication with regulatory agencies.
- Manage biostatistics resource allocation to support company's
clinical trial projects and recruit appropriate talents if
needed.
- Establish biometrics SOPs, processes and relevant quality
management system.QUALIFICATIONS:
- At least 8 years of post-graduate statistical experience in the
pharmaceutical industry.
- Statistical leadership and contribution to regulatory or
reimbursement submissions.
- Experience working effectively in a globally dispersed team
environment with cross-cultural partners.
- Excellent oral and written English communication skills.
- Ability to manage self, lead and manage others in the
successful and timely completion of all statistical activities for
a study or multiple studies from end to end.
- Ability to effectively perform complex statistical analysis and
related tasks.
- Life Cycle Drug Development Experience ---Pre-Clinical
development, clinical development, and
post-marketing---.COMPETENCIES:
- Problem Solving--Identifies and resolves problems in a timely
manner; Gathers and analyzes information skillfully; Develops
alternative solutions; Works well in group problem solving
situations; Reasons when dealing with emotional issues.
- Interpersonal Skills--Focuses on solving conflict, not blaming;
Maintains confidentiality; Listens to others without interrupting;
Keeps emotions under control; Remains open to others' ideas and
tries new things.
- Communication--Speaks clearly and persuasively in positive or
negative situations; Listens and gets clarification; Responds well
to questions; Demonstrates group presentation skills; Writes
clearly and informatively; Edits work for spelling and grammar;
Varies writing style to meet needs.
- Leadership--Exhibits confidence in self and others; Inspires
and motivates others to perform well; Effectively influences
actions and opinions of others; Accepts feedback from others; Gives
appropriate recognition to others.
- Ethics--Treats people with respect; Keeps commitments; Inspires
the trust of others; Works with integrity and ethically; Upholds
organizational values.
- Strategic Thinking--Develops strategies to achieve
organizational goals; Understands organization's strengths &
weaknesses; Analyzes market and competition; Identifies external
threats and opportunities; Adapts strategy to changing
conditions.
- Judgment--Displays willingness to make decisions; Exhibits
sound and accurate judgment; Supports and explains reasoning for
decisions; Includes appropriate people in decision-making process;
Makes timely decisions.
- Initiative--Volunteers readily; Undertakes self-development
activities; Seeks increased responsibilities; Takes independent
actions and calculated risks; Looks for and takes advantage of
opportunities; Asks for and offers help when needed.
- Innovation--Displays original thinking and creativity; Meets
challenges with resourcefulness; Generates suggestions for
improving work; Develops innovative approaches and ideas; Presents
ideas and information in a manner that gets others' attention.The
above is intended to describe the general content of and
requirements for the performance of this job. It is not to be
construed as an exhaustive statement of duties, responsibilities or
physical requirements. Nothing in this job description restricts
management's right to assign or reassign duties and
responsibilities to this job at any time. Reasonable accommodations
may be made to enable individuals with disabilities to perform the
essential functions.Brii Biosciences is an equal opportunity
employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual
orientation, gender identity or expression, pregnancy, age,
national origin, disability status, genetic information, protected
veteran status, or any other characteristic protected by law. We
value diversity and are committed to creating an inclusive
environment for team members from all backgrounds.
Keywords: Brii Biosciences, San Mateo , Biostatistician, Other , San Mateo, California
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