Associate Director, Biostatistics

Beigene, Ltd. San Mateo , CA 94401

Posted 6 months ago

Company Overview:

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 2,200 employees in China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. For more information, please visit www.beigene.com.

Position Summary:

Supporting hematology clinical development, the position will work with the clinical and regulatory team in designing clinical trials and developing the statistical analysis plan, facilitate the implementation of statistical analyses, provide statistical input to the CSR and scientific presentations/ manuscripts, perform statistical functions for submission related activities and serve as internal statistical expert in the overall program. The position will participate in process improvement, training, SOP development, enhancing statistical technical expertise and mentoring junior statisticians as a senior member of biostatistics department.

Essential Functions of the Job:

This individual will interface with clinical therapeutic area members, SAS programming, clinical data management, clinical operation, clinical pharmacology, medical writing and other functions. This position will also participate in managing vendors to ensure quality of all deliverables' and adherence to requirements/timeline.

Requirements:

  • A minimum of a Master's Degree with 8+ years of experience or a PhD in Statistics or related field with 4+ years of experience in clinical drug development is required.

  • Knowledge of SAS and/or R is strongly desirable.

  • Experiences with clinical trials and knowledge of regulatory guidance are required.

  • Hematology experience is preferred but not required. Demonstrated written and oral communication skills and ability to work within a team and work independently are required.

  • Other important requirements include interdependent/analytic thinking skills, building strategic working relationships, and good decision making capability.

Competencies:

Ethics

  • Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with BeiGene's Code of Business Conduct and Ethics, policies and procedures.

Planning/Organizing

  • Prioritizes and plans work activities; Uses time efficiently; Completes administrative tasks correctly and on time; Follows instructions and responds to management direction.

Communication

  • Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations; Writes clearly and informatively; Able to read and interpret written information.

Teamwork

  • Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed; Contributes to building a positive team spirit; Shares expertise with others.

Adaptability Able to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.

Technical Skills

  • Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability

  • Follows instructions and responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality

  • Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical

  • Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving

  • Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management

  • Communicates changes and progress; Completes projects on time and within budget.

BeiGene Is An Equal Opportunity Employer

BeiGene is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristics protected by law. As a federal contractor, BeiGene has established affirmative action programs to ensure non-discrimination and affirmative action in BeiGene's policies and practices for qualified women, minorities, protected veterans, and individuals with disabilities. The narrative portions of BeiGene's affirmative action plans for individuals with disabilities and veterans are available for inspection at our offices during normal business hours. Employees and applicants interested in inspecting these plans should contact our Human Resources department by email at us.hr@beigne.com for assistance.

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Associate Director, Biostatistics

Beigene, Ltd.