Job Description
Overview:
Work as a senior programmer on clinical and non-clinical trials; producing complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. Good knowledge of of CDISC SDTM and ADaM implementation guidelines; producing, reviewing and updating complex data specifications; creating and debugging complex macros; understanding Statistical Analysis Plans (SAPs) and output shells for day to day programming activities. Excellent team work ethos, willingness to help others and learn new skills from working in a team environment.
Responsibilities:
Employees may be required to perform some or all of the following:
• Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
• Program complex non efficacy outputs/ figures
• Perform Senior Review and Deliver QC of non- statistical output
• Develop and debug complex macros
• Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
• Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc
• Review more complex study design SAP without supervision
• Review all shells without supervision and provide feedback
• Knowledge, interpretation and implementation of current SDTM, ADAM standards
• Knowledge of FDA CRT requirements including define.xml and define.pdf
• Lead team and be responsible for creation of CRT packages
• Become familiar with and follow study documentation
• Lead a team for furthering programming development
• Ensure the principles in the PHASTAR checklist are followed rigorously
• Archive study documentation following instructions in supplied SOPs
• Act as a Lead programmer on a single study, ensuring quality and timely delivery
• Liaise with Study Statistician and Project Manager regarding resourcing and deliverables
• Responsible for study level resources
• Attend and input to company resourcing meeting
• Point of contact for programming issues for the team, proactively ensuring everything is working cohesively
• Persuade stakeholders to follow best practice within a trial
• Develop and deliver company-wide training as and when required
• Create, review and update processes and SOPs
• Take responsibility for study compliance with SOPs and processes
Qualifications:
• BAchelors or above within Computer Science, Mathematics or a Science related discipline
• SAS Programming Experience within the pharmaceutical industry
• Good awareness of clinical trial issues, design, and implementation.
• Familiarity with GCP and regulatory requirements
• Experience of programming to SDTM and ADaM standards
Work as a senior programmer on clinical and non-clinical trials; producing complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. Good knowledge of of CDISC SDTM and ADaM implementation guidelines; producing, reviewing and updating complex data specifications; creating and debugging complex macros; understanding Statistical Analysis Plans (SAPs) and output shells for day to day programming activities. Excellent team work ethos, willingness to help others and learn new skills from working in a team environment.
Responsibilities:
Employees may be required to perform some or all of the following:
• Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
• Program complex non efficacy outputs/ figures
• Perform Senior Review and Deliver QC of non- statistical output
• Develop and debug complex macros
• Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
• Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc
• Review more complex study design SAP without supervision
• Review all shells without supervision and provide feedback
• Knowledge, interpretation and implementation of current SDTM, ADAM standards
• Knowledge of FDA CRT requirements including define.xml and define.pdf
• Lead team and be responsible for creation of CRT packages
• Become familiar with and follow study documentation
• Lead a team for furthering programming development
• Ensure the principles in the PHASTAR checklist are followed rigorously
• Archive study documentation following instructions in supplied SOPs
• Act as a Lead programmer on a single study, ensuring quality and timely delivery
• Liaise with Study Statistician and Project Manager regarding resourcing and deliverables
• Responsible for study level resources
• Attend and input to company resourcing meeting
• Point of contact for programming issues for the team, proactively ensuring everything is working cohesively
• Persuade stakeholders to follow best practice within a trial
• Develop and deliver company-wide training as and when required
• Create, review and update processes and SOPs
• Take responsibility for study compliance with SOPs and processes
Qualifications:
• BAchelors or above within Computer Science, Mathematics or a Science related discipline
• SAS Programming Experience within the pharmaceutical industry
• Good awareness of clinical trial issues, design, and implementation.
• Familiarity with GCP and regulatory requirements
• Experience of programming to SDTM and ADaM standards
💡 Quick Summary
Seeking a career-building opportunity? The Senior Programmer I position is now open for candidates interested in the Remote Jobs sector. This role in Ahmedabad offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Remote Jobs is a plus.