Biostatistician

Job Description:

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

Required qualifications

• 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