6 Validation Programming Jobs

We are seeking a Principal Stat Programmer to join a leading biopharmaceutical solutions organization. This role is for a highly experienced professional who can leverage SAS and other software to develop custom programming code, manage multiple projects, and act as a technical leader for a team of statistical programmers. Roles and Responsibilities Use SAS or other software to develop custom programming code to generate summary tables, data listings, graphs, and derived datasets. Ensure outputs meet quality standards and project requirements. Perform validation programming and collaborate with project teams to resolve discrepancies. 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 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 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. Skills Required 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.

We are seeking a Principal Stat Programmer to join a leading biopharmaceutical solutions organization. This role is for a highly experienced professional who can leverage SAS and other software to develop custom programming code, manage multiple projects, and act as a technical leader for a team of statistical programmers. Roles and Responsibilities Use SAS or other software to develop custom programming code to generate summary tables, data listings, graphs, and derived datasets. Ensure outputs meet quality standards and project requirements. Perform validation programming and collaborate with project teams to resolve discrepancies. 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 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 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. Skills Required 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.

We are seeking a Principal Stat Programmer to join a leading biopharmaceutical solutions organization. This role is for a highly experienced professional who can leverage SAS and other software to develop custom programming code, manage multiple projects, and act as a technical leader for a team of statistical programmers. Roles and Responsibilities Use SAS or other software to develop custom programming code to generate summary tables, data listings, graphs, and derived datasets. Ensure outputs meet quality standards and project requirements. Perform validation programming and collaborate with project teams to resolve discrepancies. 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 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 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. Skills Required 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.

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.

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.

You will be responsible for providing statistical input to the design, analysis, reporting, and interpretation of clinical studies, as well as contributing to publications. Utilize SAS or other software to develop custom programming code for generating tables, data listings, graphs, and derived datasets as specified in the protocol or statistical analysis plan. Ensure that all outputs meet quality standards and project requirements. Perform validation programming and collaborate with other Programmers, Biostatisticians, and project team members to resolve any discrepancies or findings. Keep the project team informed of programming progress and any issues requiring their attention. Adhere to applicable SOPs and relevant regulatory guidelines. Manage scheduling and time constraints across multiple projects simultaneously. Set goals based on management priorities and adapt to timeline or priority changes by reorganizing daily workload. Prepare in advance for internal meetings, contribute ideas, and show respect for the opinions of others. Demonstrate willingness to collaborate with team members, assist with projects, and support initiatives as necessary to meet business needs. Negotiate and establish accurate time estimates for completing study activities with internal team members and statistical management. Ensure completion of project activities within the allotted timeframe. Assist in drafting regulatory submissions and stay updated with current literature and research new methodologies. Identify, develop, and implement novel statistical methodologies to support medicine development. Uphold scientific integrity and animal welfare in all activities. Interact with global statisticians and implement their recommendations locally. Create and maintain standard macros and applications to enhance department efficiency. Actively participate in process/quality improvement initiatives, standardization efforts, and other non-clinical activities. Contribute to mentoring other team members, develop training courses, present training materials, provide feedback, and guide new associates in the process. Engage in knowledge-sharing activities to foster a collaborative work environment.,