Website:
thewhiteboard.co.in
Job details:
We Are Hiring!
Lead/Principal Statistical Programmer
Experience: 8 years
Work location: Remote
Mandatory Skill: SDTM Adam TLF, Efficacy, Oncology and Study Lead
Min 2 yrs in Study lead
Primary Responsibilities
• Communicates effectively with Inference project and functional leadership concerning project issues (e.g. data, technical, timelines)
• Understand the client requirement and implement it in the project team
• Ensures alignment with Heads of US and India Operations about priorities and scope of work assignments. Proactively informs Heads of US and India Operations of issues/risks to the project and potential remediations.
• Act as the study lead in unit-based projects. Study planning and execution for quality of the deliverables and 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.
• 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.
• Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications (SDTM and ADaM), annotated CRFs, and SAS datasets and provide required programming guidance.
• Direct the programming activities and monitors progress on programming deliverables.
• Contributes to the mentoring of programmers by reviewing work and providing feedback or guiding new associates in process.
• Developing training courses, presenting training materials and conducting training as per the teams’ requirements.
• Ability to handle cross function communication with clinical team, data mangers and statistician
• Ensure adherence to compliance of standard operating procedures (SOPs) as defined in Quality Management System.
• Monitoring team performance and providing timely feedback through formal forum of appraisals
• Contributes to the technical evaluation of candidates and supports their successful integration into the organization.
Qualification
• Significant knowledge of SAS software (i.e. Base, Stat, Graph components) and general computing as relates to clinical drug development.
• Master’s degree and certification from SAS. Knowledge of other software (e.g. R) desired.
• At least 8+ years of experience as a Senior/Lead statistical programmer in a clinical industry
• 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
- • Ability to manage and mentor team technically
Interested please share your updated resume
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