Senior Clinical Programming Specialist

4 days ago

Kolkata Delhi Mumbai, India beBeeProgrammer Full time ₹ 15,00,000 - ₹ 20,00,000

We are seeking a highly experienced professional to fill a key role within our organization. This position involves leveraging SAS and other software to develop custom programming code, manage multiple projects, and act as a technical leader for a team of statistical programmers.

Key Responsibilities
  • Utilize SAS or other software to create summary tables, data listings, graphs, and derived datasets that meet quality standards and project requirements.
  • Perform validation programming and collaborate with project teams to resolve discrepancies in deliverables.
  • Manage scheduling and time constraints across multiple projects, setting goals and adapting to changes in priorities.
  • Develop specifications for datasets and outputs of any complexity.
  • Act as the lead statistical programmer, directing the activities of other programming personnel and monitoring their progress.
  • Review project documentation, such as Statistical Analysis Plans, mock shells, and programming specifications, providing feedback to reduce inefficiencies.
  • Participate in sponsor meetings, kickoff meetings, and bid defense meetings as the statistical programming representative.
  • Contribute to the mentoring of programming personnel by developing training courses and providing guidance to new associates.
  • Serve as a technical expert resource for complex programming questions, with a good working knowledge of clinical drug development, industry standards, and electronic submission requirements.
  • Contribute technical expertise to the development of programming tools and macros for standardization and efficiency.
  • Act as a subject matter expert for CDISC and other industry and regulatory requirements, providing guidance and performing compliance reviews of project deliverables.
Required Skills
  • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment.
  • Knowledge and experience in the use of CDISC Standards for regulatory agency requirements.
  • Experience with submissions to a regulatory agency is preferred.
  • Experience in mentoring others in clinical trial processes and CDISC Standards.
  • Excellent written and verbal communication skills.
  • Ability to manage concurrent programming deliverables and negotiate timelines.
  • Experience with applicable SOPs, WIs, and relevant regulatory guidelines (e.g., ICH).
  • Strong ability to maintain organized, complete, and up-to-date project documentation.

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