Principal Scientist, Biostatistics, Late-Stage Clinical Development

** Job Description*
* In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health

** Responsibilities**  **:*
* + Serves as a statistical lead in project teams.

+ Develops, coordinates, and provides biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics.

+ Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and our company Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.

+ May interact with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.

+ The incumbent may initially work in a specific disease area such as oncology.

** Primary activities**  **:*
* + 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.

+ Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.

+ 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, our company's Management, 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.

+ May represent biostatistics in regulatory interactions including presentation at advisory committee meetings

+ Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.

+ Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.

+ Involved in research activities for innovative statistical methods and applications in clinical trial development.

+ Mentors and guides junior staff in functional activities.

** Education and Minimum Requirement:*
* + PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years relevant work experience, or a Master's degree with a minimum of 9 years relevant work experience.

** Required Skills and 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…