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7 PHASTAR Jobs
Senior/Principal Programmer - MPD
PHASTAR
posted 12d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Employees may be required to perform some or all of the following:
Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
Become independent technical expert
Program complex non efficacy outputs/ figures
Perform Senior Review and Deliver QC of non- statistical output
Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
Validate and perform User Acceptance Testing (UAT) on standard macros
Identify macros requirements, communicate and perform training
Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc
Implement and coordinate development and maintenance of PHASTAR standard specifications
Be an SDTM and ADAM expert providing consultancy, advice and training
Be an CRT expert providing consultancy, advice and training
Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements
Implement and coordinate the development and maintenance of PHASTAR CRT tools
Become familiar with and follow study documentation
Initiating projects and ideas for furthering programming development
Ensure the principles in the PHASTAR checklist are followed rigorously
Develop archiving systems and processes
Act as a Lead programmer on multiple studies and project, 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
Identify areas where new processes are required
Create, review and update processes and SOPs
Take responsibility for study compliance with SOPs and processes
Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
Become independent technical expert
Program complex non efficacy outputs/ figures
Perform Senior Review and Deliver QC of non- statistical output
Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
Validate and perform User Acceptance Testing (UAT) on standard macros
Identify macros requirements, communicate and perform training
Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc
Implement and coordinate development and maintenance of PHASTAR standard specifications
Be an SDTM and ADAM expert providing consultancy, advice and training
Be an CRT expert providing consultancy, advice and training
Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements
Implement and coordinate the development and maintenance of PHASTAR CRT tools
Become familiar with and follow study documentation
Initiating projects and ideas for furthering programming development
Ensure the principles in the PHASTAR checklist are followed rigorously
Develop archiving systems and processes
Act as a Lead programmer on multiple studies and project, 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
Identify areas where new processes are required
Create, review and update processes and SOPs
Take responsibility for study compliance with SOPs and processes
Qualifications
Educated to BSc 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.
Experience of regulatory submissions and associated industry guidance
Familiarity with GCP and regulatory requirements
Knowledge of SDTM and ADaM CDISC standards
","qualifications":" SAS Programming Experience within the pharmaceutical industry
Good awareness of clinical trial issues, design, and implementation.
Experience of regulatory submissions and associated industry guidance
Familiarity with GCP and regulatory requirements
Knowledge of SDTM and ADaM CDISC standards
Educated to BSc 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.
Experience of regulatory submissions and associated industry guidance
Familiarity with GCP and regulatory requirements
Knowledge of SDTM and ADaM CDISC standards
","responsibilities":" SAS Programming Experience within the pharmaceutical industry
Good awareness of clinical trial issues, design, and implementation.
Experience of regulatory submissions and associated industry guidance
Familiarity with GCP and regulatory requirements
Knowledge of SDTM and ADaM CDISC standards
Employees may be required to perform some or all of the following:
Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
Become independent technical expert
Program complex non efficacy outputs/ figures
Perform Senior Review and Deliver QC of non- statistical output
Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
Validate and perform User Acceptance Testing (UAT) on standard macros
Identify macros requirements, communicate and perform training
Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc
Implement and coordinate development and maintenance of PHASTAR standard specifications
Be an SDTM and ADAM expert providing consultancy, advice and training
Be an CRT expert providing consultancy, advice and training
Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements
Implement and coordinate the development and maintenance of PHASTAR CRT tools
Become familiar with and follow study documentation
Initiating projects and ideas for furthering programming development
Ensure the principles in the PHASTAR checklist are followed rigorously
Develop archiving systems and processes
Act as a Lead programmer on multiple studies and project, 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
Identify areas where new processes are required
Create, review and update processes and SOPs
Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
Become independent technical expert
Program complex non efficacy outputs/ figures
Perform Senior Review and Deliver QC of non- statistical output
Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
Validate and perform User Acceptance Testing (UAT) on standard macros
Identify macros requirements, communicate and perform training
Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc
Implement and coordinate development and maintenance of PHASTAR standard specifications
Be an SDTM and ADAM expert providing consultancy, advice and training
Be an CRT expert providing consultancy, advice and training
Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements
Implement and coordinate the development and maintenance of PHASTAR CRT tools
Become familiar with and follow study documentation
Initiating projects and ideas for furthering programming development
Ensure the principles in the PHASTAR checklist are followed rigorously
Develop archiving systems and processes
Act as a Lead programmer on multiple studies and project, 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
Identify areas where new processes are required
Create, review and update processes and SOPs
Employment Type: Full Time, Permanent
Read full job description What people at PHASTAR are saying
What PHASTAR employees are saying about work life
based on 6 employees
Flexible timing
Monday to Friday
No travel
PHASTAR Benefits
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