Senior Biostatistician

You will work alongside a team of highly skilled & international Biostatisticians through the four phases of clinical trials to help us in delivering (clinical trials) results that are scientifically accurate, validated, and reproducible. Biostatisticians at IDDI are integral partners to both our multi-disciplinary clients and fellow IDDI colleagues, displaying resourceful and collaborative thinking to support new treatments and interventions in a diverse range of disease areas.

You will not only contribute to IDDI’s success by ensuring quality, high-integrity, and on-time statistical reporting for clients/sponsors but will also look at ways to innovate and increase efficiencies at every phase of clinical drug development.

You will collaborate on the design, analysis, interpretation, and communication of scientific investigations by providing therapy-focused data analysis and reporting. IDDI’s culture is scientifically driven: continuous development of our staff, invested research into new statistical methodology, and contribution to non-industry sponsored research (over 15% of IDDI projects are academic studies).

Based on your seniority, your role might also include some supervision, as well as coaching of other biostatisticians and statistical programmers to ensure our peoples’ and projects’ success. You will also receive the necessary trainings, mentoring and coaching to help you thrive in your tasks and develop further your own career.

Your role:

• Coordinate statistical tasks for individual projects
• Act as point of client contact for statistical matters for individual projects
• Write and review statistical sections of study protocols (including performing sample size calculations), clinical study reports (CSRs), and manuscripts.
• Write statistical analysis plans (SAPs) and Data Monitoring Committee (DMC) reports and Charters, including the preparation of mock table, listing, and figure (TLF) shells.
• Perform statistical analyses for Phase I to IV clinical trials following the SAP and/or mock tables, listings, and figures (TLFs). This involves:
  • Reading protocols and clinical report forms (CRFs)
  • Writing documentation of derived analysis datasets
  • Tabulating descriptive statistics using SAS and SAS macros
  • Producing inferential statistics using SAS (and R for analyses requiring procedures not available in SAS)
  • Producing graphical representations using R or SAS
  • Performing quality control of statistical programs and associated outputs
• Act as the Independent Statistician reporting to Data Monitoring Committees (DMCs)
• Perform audits of randomization procedures and balance
• Give training and/or coach other team members in your field of expertise

• Master’s degree or Doctorate (PhD, ScD) in (Bio)Statistics, or Master’s degree or Doctorate (PhD, ScD) in Epidemiology with substantial coursework in Biostatistics.
• At least 4 years of experience as a Biostatistician or statistical programmer
• Thorough knowledge of SAS, including SAS macro language
• Knowledge of R is a plus
• Experience in Data Monitoring Committees is a plus
• Sense of organization
• Accuracy and attention to detail
• Ability to work independently
• Fluent English
• Good communication skills
• Ability to solve problems