3 Applicable Sops 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.