Head of Biostatistics: USA

BeiGene

Department: Biometrics

Education Required:

Ph.D with at least 15 years experience

General Description:

Supporting oncology 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.

This individual will interface with clinical therapeutic area members, SAS programming, clinical data management, clinical operation, clinical pharmacology, medical writing and other functions.

Essential Functions of the job:

  • A PhD in Statistics or related field with 15+ years of experience in clinical drug development is required.
  • Knowledge of SAS and/or R is strongly desirable.
  • Experience with clinical trials and knowledge of regulatory guidance are required.
  • Hematology experience is preferred but not required.
  • Demonstrated written and oral communication skills.
  • Ability to work within a team and work independently.
  • Other important requirements include interdependent/analytic thinking skills, building strategic working relationships, and good decision-making capability.

Major Duties and Responsibilities:

  • Inspire, lead and develop all functions within CBDM by formulating a clear vision for the future and attracting and retaining top talent.
  • Ensure appropriate statistical designs, data collection and analysis tools and processes to clearly and robustly address the objectives of clinical studies and programs.
  • Influence and provide good-faith challenge to the broader clinical organization with respect to clinical development decisions and data interpretation.
  • Influence and provide good-faith challenge to the broader clinical organization with respect to clinical development decisions and data interpretation.
  • Lead development and optimization of Biometrics processes with specific focus on efficiency and quality, while maintaining or exceeding industry best practices.
  • Actively stay abreast of current industry analysis and reporting trends and practices.
  • Evaluate and implement innovative study designs and novel statistical methodologies as appropriate across Therapeutic Areas.
  • Provide leadership in development of creating and flexible sourcing strategies to meet the evolving demands of the BeiGene.
  • Serve as an advisor to provide an independent assessment of the robustness of Phase 2 and Proof of Concept Studies to inform clear Go/No Go decisions for subsequent development/transition to late-stage which are associated with major investment decisions.
  • Liaise with other company functions leaders to influence, shape, and drive unified strategies related to integrated clinical, translational medicine and research data, rapid hypothesis generation and other relevant enterprise efforts.

Education: Ph.D. in biostatistics, statistics and/or other relevant scientific disciplines.

Experience:

  • Minimum of 15 years of clinical development and analysis and reporting experience within the biotech/pharmaceutical industry.
  • Minimum of 5 years senior management responsibility leading through others.
  • Demonstrated success providing statistical, data management and programming leadership via direct reports.
  • Experience in regulatory interactions and submissions across multiple regions.
  • Leadership/participation in industry organizations including subject knowledge and working groups.
  • Experience developing strategies in collaboration with other cross-functional leaders
  • Experience leading cross-functional organizations through transformational change

Competencies:

Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

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, 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.

To apply for this job email your details to us.careers@beigene.com

Apply using webmail: Gmail / AOL / Yahoo / Outlook