Job Information
BeiGene Associate Director, Biostatistics in San Mateo, California
General Description:
Work with cross-functional study/project teams supporting hematology studies and interact with Clinical, Regulatory, Statistical Programming, Data Management and other Research Scientists in reviewing the data, developing and implementing the statistical analysis plan (SAP) for the clinical study report (CSR) and other health authority submission documents. Provides content for manuscripts / presentations and provides statistical support in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical projects.
Essential Duties & Responsibilities:
Develops or assists development of study protocols and SAPs and determines appropriate statistical methodology for data analysis.
Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.
Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Applies and implements basic and complex techniques to these analyses under supervision.
Prepares oral and written reports to effectively communicate results of clinical trials to the project team.
Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
Involved in research activities for innovative statistical methods and applications in clinical trial development.
Education Required:
A minimum of a master’s degree with 7+ years of experience or a PhD in Statistics or related field with 5+ years of experience in clinical drug development is required.
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.
Computer Skills: Knowledge of SAS and/or R is strongly desirable.
Other Qualifications: Experiences with clinical trials and knowledge of regulatory guidance are required. Oncology 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.
Travel: Not required
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.