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3.0 - 6.0 years
3 - 15 Lacs
pune, maharashtra, india
On-site
Job Summary: The Sr. Statistical Programmer will be responsible for end-to-end statistical programming in clinical trials, including SDTM, ADaM datasets, and tables, listings, and figures (TLFs). The role involves collaborating with biostatisticians, sponsors, and project teams to ensure high-quality programming outputs, compliance with regulatory guidelines, and efficient project delivery. Key Responsibilities: Develop custom programming code using SAS or other software to generate summary tables, listings, graphs, and derived datasets according to SAP and programming specifications. Ensure outputs meet quality standards and project requirements. Perform validation programming and collaborate with other programmers and biostatisticians to resolve discrepancies. Maintain organized, complete, and up-to-date project documentation, testing, and verification/quality control programs. Manage multiple projects, set priorities, and adapt daily workload according to project timelines. Develop specifications for datasets and outputs of varying complexity according to statistical and sponsor requirements. Anticipate and address potential programming issues to establish efficient programming practices. Prepare and contribute in internal meetings, sponsor meetings, kickoff meetings, and bid defense meetings. Act as lead statistical programmer, directing programming activities of other personnel and monitoring progress on deliverables. Review project documentation such as SAPs, mock shells, programming specifications, annotated CRFs, and SAS database designs. Provide feedback to project team members to reduce inefficiencies and improve programming quality. Mentor programming personnel, develop training materials, and guide new associates in programming processes. Transfer deliverables and perform other work-related duties as assigned. Minimal travel may be required. Qualifications: 5+ years of experience in Clinical Statistical Programming. Expertise in end-to-end programming, including SDTM, ADaM, and TLFs. Undergraduate degree in a scientific or statistical discipline, or equivalent combination of education and demonstrated programming experience. Extensive programming experience in SAS or other required software, preferably in a clinical trial environment. Excellent written and verbal communication skills; ability to read, write, speak, and understand English.
Posted 2 weeks ago
3.0 - 6.0 years
3 - 15 Lacs
thane, maharashtra, india
On-site
Job Summary: The Sr. Statistical Programmer will be responsible for end-to-end statistical programming in clinical trials, including SDTM, ADaM datasets, and tables, listings, and figures (TLFs). The role involves collaborating with biostatisticians, sponsors, and project teams to ensure high-quality programming outputs, compliance with regulatory guidelines, and efficient project delivery. Key Responsibilities: Develop custom programming code using SAS or other software to generate summary tables, listings, graphs, and derived datasets according to SAP and programming specifications. Ensure outputs meet quality standards and project requirements. Perform validation programming and collaborate with other programmers and biostatisticians to resolve discrepancies. Maintain organized, complete, and up-to-date project documentation, testing, and verification/quality control programs. Manage multiple projects, set priorities, and adapt daily workload according to project timelines. Develop specifications for datasets and outputs of varying complexity according to statistical and sponsor requirements. Anticipate and address potential programming issues to establish efficient programming practices. Prepare and contribute in internal meetings, sponsor meetings, kickoff meetings, and bid defense meetings. Act as lead statistical programmer, directing programming activities of other personnel and monitoring progress on deliverables. Review project documentation such as SAPs, mock shells, programming specifications, annotated CRFs, and SAS database designs. Provide feedback to project team members to reduce inefficiencies and improve programming quality. Mentor programming personnel, develop training materials, and guide new associates in programming processes. Transfer deliverables and perform other work-related duties as assigned. Minimal travel may be required. Qualifications: 5+ years of experience in Clinical Statistical Programming. Expertise in end-to-end programming, including SDTM, ADaM, and TLFs. Undergraduate degree in a scientific or statistical discipline, or equivalent combination of education and demonstrated programming experience. Extensive programming experience in SAS or other required software, preferably in a clinical trial environment. Excellent written and verbal communication skills; ability to read, write, speak, and understand English.
Posted 2 weeks ago
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