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