Lead Clinical Data Programmer

3 days ago

Mumbai Nagpur Thane, India beBeeStatistical Full time ₹ 9,00,000 - ₹ 12,00,000
Job Title

Sr Statistical Programmer SDTM, ADAM

Job Description
  • We are seeking a skilled professional to join our organization. This role requires the ability to use SAS and other software to develop custom programming code, ensure quality outputs, and act as a lead programmer for multiple projects.
  • The successful candidate will be responsible for using SAS or other software to develop custom programming code for summary tables, data listings, graphs, and derived datasets.
  • They will also be required to ensure outputs meet quality standards and project requirements.
  • Validation programming and collaboration with other programmers and biostatisticians will be necessary to resolve discrepancies.
  • The candidate must be able to keep project team members informed of programming progress and issues.
  • Following applicable SOPs, WIs, and relevant regulatory guidelines (ICH) is essential.
  • Maintaining well-organized and up-to-date project documentation and programs will ensure readiness for inspection.
  • The successful candidate will manage scheduling and time constraints across multiple concurrent projects.
  • Developing specifications for datasets and outputs of any complexity based on statistical and sponsor requirements will be necessary.
  • Anticipating and addressing potential programming issues will ensure efficient programming.
  • Effective internal meetings and ensuring action items are completed are crucial.
  • Negotiating and establishing accurate time estimates for project activities and completing them within the allotted timeframe will be essential.
  • The lead statistical programmer will direct the programming activities of other personnel and monitor their progress.
  • Reviewing project documentation like the Statistical Analysis Plan, mock shells, and programming specifications and providing feedback to reduce inefficiencies will be necessary.
  • Participating in sponsor meetings, kickoff meetings, and bid defense meetings as required will be necessary.
  • Contribute to the mentoring of programming personnel by developing training courses and providing feedback to new associates.
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

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