Statistical Programmer (India)

The Senior Statistical Programmer will work directly with the stakeholders to lead and contribute to statistical programming projects and to ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements.  The Senior Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets and will ensure audit readiness for all tasks. They will provide mentoring and training to statistical programming staff members and may lead or contribute to the design of new statistical programming processes or optimization of existing ones.

JOB RESPONSIBILITIES:

• Lead statistical programming activities for assigned projects, which will include projects expected to be submitted to regulatory authorities and may include pooling projects (ISS/ISE).
• Co-ordinate activities of all programmers assigned to the project, ensuring high quality, respecting project timelines and adherence to the budget.
• Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of project requirements, scope of work and timelines.
• Provide relevant training and mentorship to staff and project teams on SAS techniques and clinical trial data with respect to CDISC standards and other regulatory requirements.
• Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
• Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:
  1. clinical study reporting, e.g. ICH E3,
  2. electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11,
  3. electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM and ADaM standards.
• Understand and follow all relevant standard operating procedures (SOPs).
• Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation.
• Maintain up-to-date knowledge of programming software (e.g. SAS, R, Python) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.
• Occasionally, lead, or contribute to, the design of new statistical programming processes or optimization of existing ones to reach the best productivity, to ensure the best quality of the statistical outputs, and to reach the best customer satisfaction (internally and externally) with flexibility, reliability and responsiveness.

QUALIFICATIONS:  

Education:  BSc or equivalent with research experience, and/or MS (in a numerate discipline preferably in Statistics, Computer Science, or Mathematics). Master’s Degree preferred.

Experience:

• 6 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development with good knowledge of CDISC ADaM and SDTM, ICH Statistical and Clinical Report Guidelines.
• Experience as a lead statistical programmer working with global cross functional teams is required.

Skills:

• Fluent in English,
• Proficient in SAS,
• Project management, organizational skills, ability to manage competing priorities, and flexibility to change.
• Good understanding of drug development process, including knowledge of interfaces and interdependencies with other functions.
• Good time management and interpersonal skills,
• Written/verbal communication and presentation skills are needed along with the ability to establish and maintain effective working relationships with coworkers, managers and clients.

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