Open vacancy
Biostatistician
- Yerevan, Armenia
- Full-time
- 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.