JOB DESCRIPTION

 

JOB FUNCTION:               Clinical Development

GRADE/TITLE:                 Associate Director to Director,  Biostatistician

EMPLOYER:                     Brii Biosciences

DEPARTMENT:                Biometrics

JOB LOCATION:              Beijing, China

REPORTS TO:                  CMO

EFFECTIVE DATE:            1st Mar,2020

SUMMARY:                  This position serves as statistical lead for clinical program, providing statistical expertise to multiple studies, addressing statistical issues arising in regulatory settings, and overseeing CRO statistical/programming activities.

 

DUTIES AND RESPONSIBILITIES:

  • Work with other disciplines to build a functional biometrics department

  • Establish biometrics SOPs, processes and relevant quality management system.

  • Leads biostatistics and cross-functional initiatives.

  • Act as the subject matter 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, contribute 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.

  • Participant in recruitment process within the context of the site budget and hiring strategy, typically has decision-making authority for hiring of Biostatisticians.

  • Coach junior biostatisticians on issues associated with trial design conduct, analysis, and reporting.

  • Ensure continued career development for biostatisticians through selection of work assignments and on-going coaching and training.

  • Contribute to quality control of statistics, programming and other activities.


QUALIFICATIONS:

  • At least 8 years of post-graduate statistical experience in pharmaceutical and biotech 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 is a plus 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.