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Executive Director, Head of Statistics for Hematology Clinical Development

Company: BeiGene, Ltd. APAC
Location: Emeryville
Posted on: June 12, 2021

Job Description:

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

  • This position serves as a statistical lead and people manager for the statistics group for hematology clinical development, including team members in both China and US.

  • Develops, coordinates, and provides statistical leadership and support for BeiGene's drug development in hematology clinical development.

  • Provide strategic input for drug development plan and management review for related study documents

Essential Duties & Responsibilities:

  • Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for hematology product development.

  • Provide executive review for clinical development plan, protocol, SAP, CSR and other submission documents.

  • Review and approve responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.

  • Oversee the research activities for innovative statistical methods and applications in clinical trial development.

  • Participates in company-wide standards discussions, finalization and implementation.

  • Influence and provide good-faith challenge to the broader clinical organization with respect to clinical development decisions and data interpretation.

  • Manage a group of statisticians in hematology development in support of the ongoing trials and CDP development.

  • Liaise with other company function to influence, shape and drive unified strategies and rapid hypothesis generation and other relevant enterprise efforts.

Supervisory Responsibilities:

  • Manage a group of statisticians in hematology development in support of the ongoing trials and CDP development.

Other Qualifications:

  • PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 10 years relevant work experience.

  • Solid knowledge of statistical analysis methodologies and experimental design.

  • Good understanding of worldwide regulatory requirements and clinical trial expertise.

  • Strong oral and written communication skills. Able to function effectively in a team environment.

  • Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.

  • Experience in people management is required.

  • Experience in oncology/hematology drug development is preferred.

Competencies:

Ethics - Treats people with respect; inspires the trust of others; works with integrity and ethically; upholds organizational values.

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 opportunities for development; 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 budget.

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Keywords: BeiGene, Ltd. APAC, San Francisco , Executive Director, Head of Statistics for Hematology Clinical Development, Other , Emeryville, California

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