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Location
Sydney
Salary
$120000 - $180000 per annum, Benefits: Salary based on industry experience
Job Type
Permanent
Ref
BH-174290
Contact
Megan Luttrell
Posted
about 3 years ago
We are working with a Global Clinical Trial + Software company to secure 2 experienced Senior or Principal Statistical Programmers with their master’s at a minimum. You will join as a member of the Project Based Services (PBS) department.
 
Key Information:
  • Annual Salary – taking the lead on package based on Market rates
  • Location: WFH – simply needs to be Australia Based
  • Reporting into Singapore’s headquarters however there are views to set up an office in 2023 in either Sydney or Melbourne
  • Must have  CDISC experience
 
Your Responsibilities:
  • Lead, or contribute to, statistical programming activities on the development or Quality Control of project deliverables
    • delivering exemplary performance and solving complex technical problems to inspire other programmers,
    • ensuring an efficient collaboration with PBS global teams (Europe, India, and US)
    • being accountable for the quality, traceability, reproducibility and timeliness of statistical programming deliverables,
    • being accountable for overall client satisfaction with these deliverables,
    • maintaining a detailed project and validation plan,
    • efficiently communicating with internal and external clients,
    • ensuring budget monitoring and adherence
  • Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:
    • Clinical study reporting, e.g. ICH E3
    • Electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11
    • Electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM and ADaM standards
  • Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation
 
About You:
Years of industry experience for each level of role:
  • Senior: 5 – 7 years
  • Principal: 8 – 10 years
Additional Minimum Requirements:
  • Bachelors or Masters in a numerate discipline preferably in Statistics, Computer Science, or Mathematics
  • 3-6 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development
  • Strong SAS programming skills
  • Strong CDISC, ADAM and SDTM- production/validation.
  • Good knowledge of relevant regulatory and data submission guidelines.
  • Ability to work effectively in international teams, effectively operates within a matrix organization and with multi-disciplinary groups, excellent team player with strong interpersonal skills contributing to building the team spirit
  • Ability to educate internal and external interfaces (providers and customers) on the statistical programming processes, and the underlying regulatory requirements
 
What Next?
For further information on this role contact Megan Luttrell on 0480180307 or to confidentially apply directly via the Apply for this job button. Please apply with your CV in WORD
It is preferred if you do want to call, that you also apply so I can bring up your CV to discuss the fit