Position Responsibilities/Major Duties:
- Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development
- Is involved in clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
- Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out.
- Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis.
- Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Independently applies and implements basic and complex statistical techniques to these analyses.
- Prepares oral and written reports to effectively communicate results of clinical trials to the project team, Management team, regulatory agencies, or individual investigators.
- Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
- Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
This position has no supervisory responsibilities.
Travel may be required to about 30%.
Direct Report to: [Head of Clinical Development]
The employee will perform the job in an office environment.
This is a full-time, exempt position.
- Strong MS Excel, Word, and PowerPoint skills
- Strong problem-solving skills and attention to detail
Required Education and Experience:
- PhD or equivalent degree in statistics/biostatistics or related discipline
- A minimum of eight to ten years relevant work experience, or a Master’s degree with a minimum of 10-12+ years relevant work experience.
- Solid knowledge of statistical analysis methodologies and experimental design.
- Strong project management skills.
- Solid knowledge of statistical and data processing software e.g. SAS and/or R.
- Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
- 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 Oncology drug development is preferred
Skills and Qualifications:
- Thorough understanding of statistical principles and clinical trial methodology with the ability to practice and implement them.
- Ability to provide technical solutions to a wide range of difficult problems. Solutions are innovative, thorough and practicable, and consistent with objectives.
- Strong knowledge of clinical trial design concepts, drug regulation, and experience in the management of the statistical functional.
- Proficient in SAS or R programming preferred, and detailed knowledge of SAS procedures as well as computing tools for modelling and simulations.
- Working knowledge of regulatory guidelines and Commercial needs relating to statistical analysis, study reports and statistical components of regulatory submissions.
- Experience in representing the company and communicating with health authorities for biostatistical approach
- Able to manage multiple projects simultaneously, to manage and coordinates limited resources to produce quality deliverables within timelines for competing priorities, and to be flexible when priorities change.
- Highly effective written, oral, and interpersonal communication skills as well as ability to work in interdisciplinary contexts outside statistics. Demonstrates leadership skills with effective communication including being able to explain methodology and consequences of decisions in lay terms; able to translate requests to meaningful and relevant hypotheses/statistical questions
- Experience and/or capability of building and leading a statistical team including biostatistics and statistical programming
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
If you are interested, please send your resume to