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3.0 - 6.0 years
3 - 6 Lacs
aurangabad, west bengal, india
On-site
We are seeking a Sr Statistical Programmer SDTM, ADAM & TLFs 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. Roles and Responsibilities Use SAS or other software to develop custom programming code for summary tables, data listings, graphs, and derived datasets ( TLFs ). 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. Conduct effective internal meetings and ensure action items are completed. Negotiate and establish accurate time estimates for project activities and complete them within the allotted timeframe. Act as the lead statistical programmer, directing the programming activities of other personnel and monitoring their progress. Review project documentation like the Statistical Analysis Plan , mock shells, and programming specifications, providing feedback to reduce inefficiencies. Participate in sponsor meetings, kickoff meetings, and bid defense meetings as required. Contribute to the mentoring of programming personnel by developing training courses and providing feedback to new associates. Transfer deliverables upon project completion. Skills Required 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.
Posted 2 weeks ago
3.0 - 6.0 years
3 - 6 Lacs
thane, maharashtra, india
On-site
We are seeking a Sr Statistical Programmer SDTM, ADAM & TLFs 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. Roles and Responsibilities Use SAS or other software to develop custom programming code for summary tables, data listings, graphs, and derived datasets ( TLFs ). 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. Conduct effective internal meetings and ensure action items are completed. Negotiate and establish accurate time estimates for project activities and complete them within the allotted timeframe. Act as the lead statistical programmer, directing the programming activities of other personnel and monitoring their progress. Review project documentation like the Statistical Analysis Plan , mock shells, and programming specifications, providing feedback to reduce inefficiencies. Participate in sponsor meetings, kickoff meetings, and bid defense meetings as required. Contribute to the mentoring of programming personnel by developing training courses and providing feedback to new associates. Transfer deliverables upon project completion. Skills Required 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.
Posted 2 weeks ago
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