We are hiring Lead Clinical Data Mangers in the US who will be members of cross-functional development teams and will contribute to trial data collection, reconciliation, cleaning and archival. The Lead CDMs will develop collaborative relationships and work effectively with the Inference projector manager, database developers, statisticians, statistical programmers and other members of the study team.

Primary Responsibilities :

• Lead and conduct all Data Management activities required for global clinical trials ensuring study conduct is in accordance with Inference Standard Operating Procedures (SOPs) and ICH/GCP. 
• Coordinate the work of global staff assigned to the project. Oversee the data management strategy and project plans for collection and integration of all clinical data including but not limited to, case report forms (CRF) data, lab data, biomarker data, and patient reported outcomes. 
• Provide training on procedures and systems. Create project-related materials. Track project progress and issue status reports. Ensure the achievement of key milestones relating to the function. Attend internal and external meetings.
• Communicates effectively with Inference project and functional leadership concerning project issues (e.g. data, technical, timelines), and  potential remediations.

Qualifications :

• Significant academic training in statistics, biostatistics or relevant areas of study. Master’s degree in statistics or biostatistics required. PhD degree in a field where significant statistical course-work has been a requirement will also be considered (e.g. genetics, economics, psychology).
• A University degree (BS), preferably in science
• 8 to 12 years of successful Clinical Data Management experience including the lead of Phase 1 to 3 trials from the start till database lock
• Knowledge of EDC platforms such as RAVE, MEDRIO
• Effective project management skills, cross-functional team leadership and organizational skills
• Good planning and analytical skills and excellent communication skills
  
• Ability to be flexible and adapt quickly to the changing needs of the organization

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We are looking for Biostatisticians who will be members of cross-functional development teams and will contribute to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, they may have responsibilities for integrated summaries and/or supporting regulatory submissions. These individuals will develop collaborative relationships and work effectively with the Inference Sr. Director of Statistics, Medical Monitor, Projector Manager, Data Manager, PK Scientist, and other members of the study team. Biostatisticians will be individual contributors and will report to a Biostatistics Manager.

Primary Responsibilities :

• Communicates effectively with Inference project and functional leadership concerning project issues (e.g. data, technical, timelines).
• Ensures alignment with Project Manager and Heads of US and India Operations with regard to priorities and scope of work assignments. Proactively, informs Project Manager and Heads of US and India Operations of issues/risks to the project and potential remediations.
• Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access.
• Translates scientific questions into statistical terms and statistical concepts into layman terms.
• Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, clinical study reports, and other study level specification documents
• Ensures programming team understands the nature of the clinical data being collected and the approaches to summarizing the information.

Qualifications :

• Significant academic training in statistics, biostatistics or relevant areas of study. Master’s degree in statistics or biostatistics required. PhD degree in a field where significant statistical course-work has been a requirement will also be considered (e.g. genetics, economics, psychology).
• Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements
• Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals
• Ability to be flexible and adapt quickly to the changing needs of the organization
• Ability to organize multiple work assignments and establish priorities

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We are searching for Senior Statistical programmers who can provide comprehensive programming expertise to support the analyses of data in the context of sponsors’ development plans and regulatory submissions. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Statistical programmers are expected to develop collaborative relationships and work effectively within Inference. This position reports to a Statistical Programming Manager and has no direct supervisory responsibilities but provides mentoring to more junior programmers.

Primary Responsibilities :

• Communicates effectively with Inference project and functional leadership concerning project issues (e.g. data, technical, timelines).
• Ensures alignment with Project Manager and Heads of US and India Operations about priorities and scope of work assignments.       Proactively informs Project Manager and Heads of US and India Operations of issues/risks to the project and potential remediations.
• Provides comprehensive programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis. Drives the development and implementation of innovative strategies and technologies to improve programming efficiency.
• Reviews key planning documents (e.g., protocol, statistical analysis plan, mock shells) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements.
• Supports the development of unambiguous and robust programming specifications for programming work.
• Identifies opportunities for increased efficiency and consistency within Inference. Contributes to globalization, improvement and standardization of processes, standards and tools.

Qualifications :

• Significant knowledge of SAS software (i.e. Base, Stat, Graph components) and general computing as relates to clinical drug development.
• Graduate degree and certification from SAS. Knowledge of other software (e.g. R) desired.
• At least 5 years of experience as a statistical programmer in a clinical environment
• Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements
• Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals
• Ability to be flexible and adapt quickly to the changing needs of the organization
• Ability to organize multiple work assignments and establish priorities

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We are looking for Statistical Programmers who can provide comprehensive programming expertise to support the analyses of data. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Statistical programmers develop collaborative relationships and work effectively within Inference. This position reports to a Statistical Programming Manager and has no direct supervisory responsibilities.

Primary Responsibilities :

• Communicates effectively with functional leadership concerning project issues (e.g. data, technical, timelines).
• Provides comprehensive programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis. Drives the development and implementation of innovative strategies and technologies to improve programming efficiency.
• Reviews key planning documents (e.g., protocol, statistical analysis plan, mock shells) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements.
• Supports the development of unambiguous and robust programming specifications for programming work.
• Identifies opportunities for increased efficiency and consistency within Inference. Contributes to globalization, improvement and standardization of processes, standards and tools.

Qualifications :

• Significant knowledge of SAS software (i.e. Base, Stat, Graph components) and general computing as relates to clinical drug development.
• Graduate degree or certification from SAS preferred. Knowledge of other software (e.g. R) desired.
• Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements
• Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals
• Ability to be flexible and adapt quickly to the changing needs of the organization
• Ability to organize multiple work assignments and establish priorities
• Excellent verbal and written communications skills

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