Advanced Clinical Solutions Lead

1 day ago

Hyderabad, Telangana, India beBeeStatistical Full time ₹ 70,00,000 - ₹ 1,10,00,000
Job Overview

Our organization is dedicated to delivering innovative clinical solutions that enhance the drug development journey. We strive to improve lives by approaching each opportunity with foresight, character, resilience, and innovation.

Our goal is to provide customized solutions that help clients achieve better outcomes through candid conversations and proactive issue anticipation.

The Senior Statistical Programmer will be responsible for providing programming support for clinical trials, building on their experience in all required areas of a Statistical Programmer II.

Key Responsibilities:

  • Exceed expectations and responsibilities of a Statistical Programmer II by implementing advanced statistical techniques and ensuring timely delivery of high-quality results.
  • Understand and implement industry standards such as CDISC and other regulatory requirements.
  • Develop and maintain SAS programming conventions to ensure consistency and efficiency across projects.
  • Lead programming efforts on assigned studies, coordinating activities and ensuring accuracy and completeness.
  • Manage project timelines, creating and maintaining schedules to meet deadlines.
  • Support the development of tools and macros to improve quality and efficiency of processes.
  • Prepare programming specifications for SDTM, ADaM, and other derived datasets.
  • Apply knowledge of SAS programming to develop and validate statistical outputs according to the statistical analysis plan and other specifications.
  • Perform ad hoc analyses of current and legacy databases, leveraging expertise in data management and statistical analysis.
  • Review and provide input on case report form design, ensuring alignment with project goals.
  • Mentor junior programmers, sharing expertise and best practices.
  • Monitor scope of work versus actual work, alerting management to potential change orders or resourcing needs.
  • Collaborate with cross-functional teams including programmers, statisticians, data managers, database programmers, and others to deliver accurate and high-quality statistical outputs.
  • Contribute to the development and revision of departmental Standard Operating Procedures (SOPs).
  • Participate in business development activities, supporting RFI completion, proposal development, bid defense participation, and attendance at industry/scientific meetings.

Additional Responsibilities:

  • Assist in the preparation and review of monthly financial reporting.
  • Promote visibility outside the functional area and effectively interact cross-functionally and in industry.
  • Participate in candidate interviews, contributing to the selection process.
  • Perform other duties as requested by management.

Requirements:

  • A degree in Statistics, Computer Science, or a closely related field; work experience may be substituted for degree.
  • A minimum of 4 years direct SAS programming experience in a pharmaceutical development or CRO environment.
  • Good knowledge of medical terminology and conduct and analysis of clinical trials.
  • Knowledge of relevant industry data standards, e.g., CDISC SDTM, ADaM, etc.
  • Excellent oral and written communication skills, organizational skills, and attention to detail are required.

Our organization values diversity, allowing us to effectively draw on different perspectives and enhance our efficiency and effectiveness. We seek talented individuals from various backgrounds and cultures to join our team.

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