With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Oracle immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients!
We are looking for a Biostatistician who will be responsible for programming statistical analyses and tables, assists in development of statistical analysis plans, validation of other team members’ output, provide statistical input in study documents, and be a junior level point of contact for clients.
Also, this individual will be responsible for programming of statistical analyses, and tables, figures, and listings (TFLs) within SAS for clinical trials and non-interventional studies (NIS) using propriety program templates or Sponsor macros.
Responsibilities
What you will do:
- Generation of derived analyses datasets in CDISC standard (ADaM/SDTM).
- Assists in the development of statistical analysis plans (SAPs).
- Validation of programs and statistical output (TFLs) of other team members.
- Providing basic statistical input in study documents such as CRF and DMP.
- Assists in performing meta-analyses of statistical results from different published studies.
- Assists in review of statistical parts of clinical study reports and of the accurate interpretation of results.
- Develops relationships with clients and is considered a junior point of contact by clients of project requests/questions.
- Prioritises and manages workload with minimal input from Team Lead to ensure agreed deadlines are met.
- Provides expertise to internal and external stakeholders to ensure all materials / outputs comply with relevant SOPs, regulations and guidelines.
- Cooperation in further development of internal guidelines and SOPs.
Required experience:
- Master's degree or a bachelor's degree in relevant life sciences or scientific field (e.g., Biostatistics, Statistics, Epidemiology, Economics, Analytics, Mathematics, Biomedical Engineering) and a practical experience, relevant professional education, or equivalent.
- Previous work experience with CDISC and SDTM / ADAM is required.
- A relevant prior professional experience as a biostatistician in the Life Sciences industry, along with prior work in a CRO is preferred.
- Excellent communication skills (written and verbal) in English – C1 as a minimum.
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