Principal Stats Programmer

Bengaluru - India

Monthly Salary: Not Disclosed

Posted on: 6 hours ago

Vacancies: 1 Vacancy

Job Summary

Summary of Responsibilities:

Perform the role of the Lead Statistical Programmer.
Plan execute and oversee all programming activities on a study including but not limited to resource estimation working within budget meeting timelines maximizing quality interaction with other departments and the client etc.
Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs and perform QC of SDTM ADaMs and TFLs.
Produce Define XML/PDFs Analysis Results Metadata (ARM) aCRFs and Reviewers Guides to support SDTMs and ADaMs.
Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Fortrea and Client standards.
Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective.
Mentor less-experience programmers in the processes around SDTMs ADaMs and TFLs ensuring adherence to department practices and processes.
Present and share knowledge at department meetings.
Respond to QA and client audits and support qualification audits.
Contribute to proposal activities and participate in bid defenses meetings in order to win new business.
Continually identify and suggest ways to improve the efficiency quality and productivity of statistical programming.
And all other duties as needed or assigned.

Qualifications (Minimum Required):

Bachelors degree preferably in mathematics statistics computing life science health science or related subjects.
Experience and/or education plus relevant work experience equating to a Bachelors degree.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Language Skills Required: o Speaking: Yes English required o Writing/Reading: Yes English required

Experience (Minimum Required):

Typically 6 years of SAS programming experience in the CRO or Pharmaceutical industry or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
Experience as lead statistical programmer on complex studies in clinical research.
Knowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines e.g. Biostatistics and Clinical Data Management.
Broad knowledge of all CDISC requirements related to SDTM and ADaM including Reviewers Guide and submission standards.

Physical Demands/Work Environment:

Office or home-based environment as requested by the line manager.

Learn more about our EEO & Accommodations request here.

Required Experience:

Staff IC

Summary of Responsibilities:Perform the role of the Lead Statistical Programmer.Plan execute and oversee all programming activities on a study including but not limited to resource estimation working within budget meeting timelines maximizing quality interaction with other departments and the client...

Summary of Responsibilities:

Perform the role of the Lead Statistical Programmer.
Plan execute and oversee all programming activities on a study including but not limited to resource estimation working within budget meeting timelines maximizing quality interaction with other departments and the client etc.
Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs and perform QC of SDTM ADaMs and TFLs.
Produce Define XML/PDFs Analysis Results Metadata (ARM) aCRFs and Reviewers Guides to support SDTMs and ADaMs.
Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Fortrea and Client standards.
Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective.
Mentor less-experience programmers in the processes around SDTMs ADaMs and TFLs ensuring adherence to department practices and processes.
Present and share knowledge at department meetings.
Respond to QA and client audits and support qualification audits.
Contribute to proposal activities and participate in bid defenses meetings in order to win new business.
Continually identify and suggest ways to improve the efficiency quality and productivity of statistical programming.
And all other duties as needed or assigned.

Qualifications (Minimum Required):

Bachelors degree preferably in mathematics statistics computing life science health science or related subjects.
Experience and/or education plus relevant work experience equating to a Bachelors degree.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Language Skills Required: o Speaking: Yes English required o Writing/Reading: Yes English required

Experience (Minimum Required):

Typically 6 years of SAS programming experience in the CRO or Pharmaceutical industry or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
Experience as lead statistical programmer on complex studies in clinical research.
Knowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines e.g. Biostatistics and Clinical Data Management.
Broad knowledge of all CDISC requirements related to SDTM and ADaM including Reviewers Guide and submission standards.

Physical Demands/Work Environment: