Job Description

My client, a US MNC whom is a leading Healthcare IT software company is looking out for a competent Senior Statistical Programmer to support their company's growth to new levels: Requirements

• Lead, or contribute to, statistical programming activities on PBS projects (development or QC of deliverables):
  o delivering exemplary performance and solving complex technical problems to inspire other programmers,
  o ensuring an efficient collaboration with PBS global teams (Europe, India, and US)
  o being accountable for the quality, traceability, reproducibility and timeliness of statistical programming deliverables,
  o being accountable for overall client satisfaction with these deliverables,
  o maintaining a detailed project and validation plan,
  o efficiently communicating with internal and external clients,
  o ensuring budget monitoring and adherence
• Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:
  o Clinical study reporting, e.g. ICH E3
  o Electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11
  o Electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM and ADaM standards
• Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers…)
• Understand, follow and ensure adherence to all BDM SOP as well as any other relevant SOPs.
• Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation

Qualifications:

• BSc or equivalent with research experience, and/or MS (in a numerate discipline preferably in Statistics, Computer Science, or Mathematics)
• 8+ years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development, with 2+ years of CRO experience
• Experience as a lead statistical programmer on several concurrent projects
• Strong SAS programming skills
• Strong CDISC ADaM and SDTM- production/validation.
• Good understanding of drug development, including knowledge of interfaces and interdependencies with other functions.
• Good knowledge of relevant regulatory and data submission guidelines.
• Project management skills
• Fluent in English (French and/or German is a plus)
• 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

How to Apply Interested applicants may apply by sending in your updated résumé (in MS Word format) to my email or apply directly:
Consultant: Tan Jun Jie
EA personnel reg. no.R1878852
EA License No. 17C8502