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Lead Statistical Programmers

Employer
Labcorp Drug Development
Location
Dublin, Ireland
Salary
Competitive
Start date
13 Sep 2022
Closing date
26 Sep 2022

View more

Discipline
R & D , Bioinformatics
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

  • 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
  • Candidates must be fluent in English language (both verbal and written) and have the automatic right to work in the relevant country


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
  • Participate in partnership Bid Defenses in order to win new packages of business
  • Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming


Job Qualifications
  • BSc, preferably in computing, life science, mathematical or statistical subject
  • You must have some previous experience of working as a Lead Statistical Programmer in either a biotech, CRO or pharma company using SAS.
  • Knowledge of CDISC requirements
  • Positive attitude and willingness to learn and contribute in a team setting and communicate effectively within the team environment
  • Good organization skills and the ability to prioritize own work
  • Self motivation and ability to work independently
  • A cooperative and team-oriented approach
  • Candidates must be fluent in English language (both verbal and written)


Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

For more information about how we collect and store your personal data, please see our Privacy Statement .

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

hub-icon-labcorpPlease visit our Careers Hub on

https://www.pharmiweb.jobs/minisites/labcorp-drug-development-careers-hub/

 

 

 

Find Us
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom
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