Lead Statistical Programmers

7 days ago

Centurion, South Africa Labcorp Full time

**Lead Statistical Programmers** required to work for Labcorp Drug Development
- Permanent, full time roles, 0.8 FTE considered
- We can hire at the following job titles:

- Senior Statistical Programmer
- Principal Statistical Programmer
- Senior Principal Programmer
- We have opportunities working within the following business units:

- CPS - Clinical Pharmacology Services - Phase I Healthy Volunteer Studies, Multiple Therapy Areas, Multiple Sponsors
- CDS Oncology - Clinical Development Services - Phase I & II Patient Oncology Studies, Multiple Sponsors
- CDS Late Phase - Clinical Development Services - Phases II-IV, Multiple Therapy Areas (including oncology), Multiple Sponsors
- FSP - Functional Service Provision - Working dedicated to 1 Sponsor, various opportunities in early and late phase, oncology and non-oncology. Some FSP agreements mean you are outsourced to Sponsor, others you work internally
- Office based or home based anywhere in these countries:

- Austria
- Belgium
- Bulgaria
- Czech Republic
- Estonia
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Latvia
- Lithuania
- Netherlands
- Poland
- Portugal
- Romania
- Serbia
- Slovakia
- South Africa
- Spain
- Sweden
- UK
- Ukraine
- You must have previous Lead Statistical Programmer experience gained within a biotech, CRO or pharma company

**Job Primary Functions for Senior Statistical Programmer**
- 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 SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
- Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and Reviewers Guides to support SDTMs and ADaMs
- Develop specifications for SDTMs and ADaM datasets
- Review SAPs and TFL shells from a programming perspective for studies
- Mentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLs
- Present and share knowledge at department meetings
- Respond to QA and client audits, and support qualification audits
- Identify processes within programming that will increase productivity, quality and efficiency

**Job Primary Functions for Principal Statistical Programmer**
- 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 company 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

**Job Primary Functions for Senior Principal Statistical Programmer**
- Perform the role of a Lead Statistical Programmer including leading oversight of partnership programs
- 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 complex 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 Covance 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 programmers in the processes around SDTMs, ADaMs and TFLs and Study Lead processes, ensuring adherence to department practices and processes
- Facilitate advanced technical expertise
- Respond to QA and client audits and represent the department in all types of audits
- Participa

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