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Senior Principal Statistician Jobs
Company | Merck |
Address | North Wales, PA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Research Services,Biotechnology Research,Pharmaceutical Manufacturing |
Expires | 2023-07-11 |
Posted at | 10 months ago |
- Interacts with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.
- Serves as a statistical lead in project teams.
- Lead, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Late Development Statistics.
- Lead the interaction with Clinical, Regulatory, Statistical Programming, Data Management, and other our company's Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
- Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
- 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.
- Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
- Mentors and guides junior staff in functional activities.
- Lead research activities for innovative statistical methods and applications in clinical trial development.
- 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.
- Represent biostatistics in regulatory interactions including presentation at advisory committee meetings
- Collaborates in publication of research results in areas of applications.
- 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.
- 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.
- 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.
- Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development
- Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non-statistical group and other committee works as needed
- Lead a team of statistical and/or programing staff assigned to a development project as needed
- Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis.
- 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.
- Excellent oral and written communication skills and strong leadership in a team environment.
- Strong project management skills.
- Solid knowledge of statistical and data processing software e.g. SAS and/or R.
- Solid knowledge of statistical analysis methodologies and experimental design.
- Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development.
- Strong scientific leadership in design and analysis of clinical trials
- Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.
- Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
- Publications in peer reviewed statistical/medical journals.
- An understanding of biology of disease and drug discovery and development.
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