Associate Director India

Year    Hyderabad, Telangana - Secunderabad, Telangana, India

Job Description


Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development. As Associate Director, you will leverage your advanced SAS programming and strong CDISC (ADaM / SDTM) skills to lead and/or support one or more Phase I-IV studies. You will report to the Sr. Director, Statistical Programming. Summary of Job Responsibilities: Responsible for participating in strategy and resource planning in collaboration with client and project management to ensure a coordinated and efficient approach for high quality statistical programming deliverables. Promote communication and adequate information flow with client and project management to align strategic objectives. Responsible for recruiting, hiring, training, development, setting goals/objectives, performance assessment, in collaboration with Senior Director/Director, Statistical Programming. Direct the development of internal statistical programming WIs/SOPs and ensure adherence to all relevant internal or client WIs/SOP when applicable. Provide timelines and allocate resources for statistical programming deliverables. Conduct resource planning for statistical programming. Ensure the statistical programming systems, processes and deliverables are fully aligned with the regulatory requirements, in particular concerning Clinical study reporting, e.g. ICH E3, electronic records handling, electronic submission of clinical data to agencies including e-CTD guidance and CDISC SDTM and ADaM standards. Develop and manage the statistical programming function with respect to statistical programming strategy, deliverables, processes, and professional development. Lead the optimization and implementation of the statistical programming processes to reach the best productivity, to ensure the best quality of the statistical outputs, and to reach the best customer satisfaction with flexibility, reliability and responsiveness. Qualifications and Experience: Minimum Education: Bachelor or Advanced degree (in a scientific discipline preferably in Statistics, Computer Science, Mathematics, Biology, IT, Social Sciences, etc.) Minimum Work Requirements: At least 10 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development Some experience as a statistical programming manager leading an international team. Consistent experience as a lead statistical programmer on several concurrent projects Skills: Proficient in SAS Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions. Strong knowledge of relevant regulatory and data submission guidelines. Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to statistical programming processes, management of statistical programmers and development of managers. Strong project management, leadership and management skills Fluent in English (French and/or German is a plus)

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Job Detail

  • Job Id
    JD3049029
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Hyderabad, Telangana - Secunderabad, Telangana, India
  • Education
    Not mentioned
  • Experience
    Year