Relocation is not designated for this position.
Major Responsibilities and Accountabilities:
* Prepares summarized information or integrated analysis environments for clinical study team members
* Creates tools and solutions for partners that integrate statistical methods and data from various sources in order to help them explore and gain insight into the data and statistical algorithms of interest. These tools may also be developed to provide evidence and guidance to support decision making
* Uses statistical data visualization and interactive data visualization to explore and to analyze data, and to communicate findings with scientific partners
* Lead statistical programming activities
* Assess and clarify requirements, contribute to developing programming specifications, providing statistical programming solutions and ensure their efficient implementations
* Determines and develops approaches to meet the project requirements
* Responsible for accuracy and reliability of results. Builds and monitors quality in every aspect of job activities
* Has a familiarity with the types of risks associated with a study and the impact on the quality of deliverables. Implements the risk based quality control accordingly
* Provides technical solutions to a wide range of problems. Independently determines and develops approach to solutions
* Builds and maintains effective working relationships with cross-functional teams. Builds mutual purpose with team members
* Considers strategies that will enable a smooth transition of a study or other task, if changes were to occur (e.g. with 'fluid resourcing' changes)
* Negotiates alternative timelines based on resourcing / priority constraints
* Negotiate effectively with customers for reasonable timelines and scope
* Contribute to user aspects of technical infrastructure or business process initiatives with a focus on statistical programming, data process and analysis reporting procedures
* Adapts to changing circumstances, policies, work assignments, and/or team members.
* Has programming experience with object oriented languages, experience with software design and creating graphical user interfaces and makes appropriate use of this knowledge
* Has a good foundation in computer science and has strong knowledge in multivariate and computational statistics including statistical learning, dimensionality reduction and simulation
* Knowledge in high dimensional genomic data and experience in analyzing biomarker data preferred
Technical Requirement: Requirements
M.S. or advanced degree in Data Science related field (e.g. Statistics, Mathematics, Epidemiology, Health Economics, Outcomes Research, Computer Science, Bioinformatics, etc…) with solid Biology knowledge; Advanced programming experience with R, Python, SAS and/or other statistical and/or analytical and visualization software packages;. Knowledge in clinical research with emphasis in the development and support of the analysis of clinical trial and human genomic data is preferred.
Experience and/or Competencies Required:
* Demonstrated ability to rapidly adapt to changing project and strategic requirements with a proven ability to understand and become familiar with therapeutic and diverse disease areas
* Curiosity and interest in the scientific aspects of drug development projects & advanced technology in analytics and data visualization
* Analytical and solution driven mind-set. Applied experience in extensive independent data exploration and insight generation including cleansing for analysis, visualizing, preliminary modeling and interpreting evidence.
* Knowledge and experience on data processing and analysis of high dimensional data.; Ability and willingness to work with incomplete/dirty data and knowledge of methods how to properly manage the situation. Able to assess the added uncertainty of the conclusions driven by this kind of data.
* Experience leading projects with passion and able to motivate others, especially without formal authority over them
* Able to build strong working relationships with stakeholders within and outside of Biometrics and work interactively with stakeholders to understand and define requirements and provide potential solutions
* Excellent communication skills to understand or help to form the right scientific question; Strong problem solving, negotiation, influencing & consultancy skills with attention to detail
* Ability to see the big picture; Awareness of changing trends in industry
* Knowledge of drug development (e.g pre-clinical, clinical development, post-marketing and Personalized Health Care) and ICH GCP guidelines, data source, statistical concepts, analytical methodology and technology.
* Positive energy to work in collaborative and dynamic team setting