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France Keyrus Biopharma

Statistical Programmer Oncology USA H/F

Job Description

Keyrus Biopharma is recruiting a Statistical Programmer in oncology for our client within life science industry based in Boston:

  • To develop analysis data sets (ADAM)
  • To prepare submission package
  • To develop statistical programs of analyses for CSR, summary documents, regulatory activities
  • To participate to the creation of regulatory documentation (programming specifications, define,…)
  • To participate in answers to questions from regulatory activities

Profile

  • Master in biostatistics with at least 2 years of experience as biostatistician or programmer in the context of clinical trials and therapeutic development in oncology
  • Proficiency in SAS software programming,
  • Experience CDISC (SDTM/ADaM in particular),
  • Experience in FDA submission

Who we are

Keyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.

Publication date

09.01.2019