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Statistical Programmer Lead

3 weeks ago

Pune Aurangabad Nashik, India beBeeClinicalProgramming Full time US$ 90,000 - US$ 1,20,000

We are seeking an experienced Clinical Programming Specialist to join a leading biopharmaceutical solutions organization. This role is for a skilled professional who can use SAS and other software to develop custom programming code, ensure quality outputs, and act as a lead programmer for multiple projects, driving success by delivering therapies to patients faster.

Key Responsibilities
  • Develop custom programming code for summary tables, data listings, graphs, and derived datasets using SAS or other required software.
  • Ensure outputs meet quality standards and project requirements.
  • Perform validation programming and collaborate with other programmers and biostatisticians to resolve discrepancies.
  • Keep project team members informed of programming progress and issues.
  • Follow applicable SOPs, WIs, and relevant regulatory guidelines (ICH).
  • Maintain well-organized and up-to-date project documentation and programs, ensuring readiness for inspection.
  • Manage scheduling and time constraints across multiple concurrent projects.
  • Develop specifications for datasets and outputs of any complexity based on statistical and sponsor requirements.
  • Anticipate and address potential programming issues to ensure efficient programming.
Required Skills and Qualifications
  • Proven expertise in end-to-end clinical statistical programming (SDTM, ADAM & TLGs).
  • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment.
  • Undergraduate degree, preferably in a scientific or statistical discipline.
  • Excellent written and verbal communication skills.
  • Ability to read, write, speak, and understand English.
  • Strong project management skills to manage multiple projects and timelines.
  • Experience in performing validation programming and troubleshooting.