MSD Malaysia
* 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, our Company's 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.* Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.* Experience in immunology and/or respiratory therapeutic area is desirable.**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 #J-18808-Ljbffr
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.* 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.* Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.* Experience in immunology and/or respiratory therapeutic area is desirable.**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 #J-18808-Ljbffr