Senior Principal Statistician

* Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development
* Lead a team of statistical and/or programing staff assigned to a development project as needed
* Lead biostatistics in early or late 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.
* May lead a team of statisticians and statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements
* Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
* 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, regulatory agencies, or individual investigators.
* Represent biostatistics in regulatory interactions including presentation at advisory committee meetings
* Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
* Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
* Lead research activities for innovative statistical methods and applications in clinical trial development.
* Collaborates in publication of research results in areas of applications.
* Mentors and guides junior staff in functional activities.
* Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non-statistical group and other committee works as needed

Education and Minimum Requirement:
PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or a master’s degree with a minimum of 12 years relevant work experience.
* Solid knowledge of statistical analysis methodologies and experimental design.
* Strong scientific leadership in design and analysis of clinical trials
* Strong project management skills.
* Solid knowledge of statistical and data processing software e.g. SAS and/or R.
* Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
* Excellent oral and written communication skills and strong leadership in a team environment.
* Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development.
* Publications in peer reviewed statistical/medical journals.
* Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.
** Los Angeles Residents Only:
** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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