Open vacancy

Biostatistician

NoyMed CRO is seeking a disciplined and detail-oriented Biostatistician to join our team and assist in all aspects of biostatistics activities of the company.

Responsibilities:

Developing and supervising of (Junior) Biostatistician and (Junior/Senior) SAS Programmer in the development of:

  • statistical analysis plans (SAPs)
  • table, figure and listing (TFLs) shells
  • analysis data model (ADAM) specifications
  • analysis tables, figures and listings (TFLs) in accordance with the required specifications
  • study data tabulation model (SDTM) datasets from the clinical databases according to SDTM guidelines using Statistical Analysis Software (SAS)
  • analysis datasets according to ADAM specifications
  • statistical analysis reports (SARs)

Assisting and supervising of Junior/Mid Biostatistician in:

  • development and review of protocol statistical parts
  • performing sample size calculations
  • case report forms (CRFs) and annotated CRFs review
  • clinical study reports (CSRs) development and review
  • standard operating procedures (SOPs) development review

Performing quality control (review and/or validate) and supervising Junior/Mid Biostatisticians perform quality control with providing the following feedback to the Project Manager and/or the Project Statistician for:

  • statistical analysis plans (SAPs)
  • table, figure and listing (TFLs) shells
  • table, figure and listing (TFLs) code
  • the programmed analysis datasets
  • statistical analysis reports (SARs)

Providing trainings for (Junior/Senior) SAS programmers, (Junior/Middle/Senior) Biostatisticians

Document projects results according to established company practices

Providing assumptions for Biostatistics and Statistical programming activities based on the study protocol/synopsis

Performing all tasks within the specified timelines and controlling the timelines of all delegated tasks

Requirements:
  • Master of Science in Statistics, Mathematics, Medicine, or related discipline. Ph.D. as an advantage
  • More than 2.5 years of work experience in a similar field
  • Strong statistical skills in clinical trials (e.g. experimental designs, statistical modeling, exploratory data analysis, sample size determination, etc.)
  • Prior experience with clinical programming more than 2 years in SAS/R/Stata
  • SAS programming skills (at least BASE and STAT). SAS certificate as an advantage
  • ICH/GCP certification
  • Familiarity with CDISC standards and 21 CFR part 11
  • Attention to detail, ability to work independently and in a team, to take responsibility and to make decisions, problem-solving skills
  • Competent in written and oral English communication skills
Additional information

If you are interested in this position, please apply now by sending your CV to [email protected],  mentioning “Biostatistician” in the Subject Line of your e-mail.

Please note that only shortlisted candidates will be contacted for the interview.

Application deadline: March 2nd, 2024