Proclinical are partnering with a CRO who are currently recruiting for an individual to join their team. This role is on a permanent basis with the ability to work in the UK remotely. The opening position is for a Biostatistician at a senior level.
- Train and mentor statisticians on non-project-linked tasks.
- Offer consultation on experimental design, statistical strategies, and approaches for the purpose of examining safety and efficiency of drug products.
- The ideal candidate will prepare for and attend internal and third-party study audits pertinent to statistics.
- Evaluate and QC statistical deliverables such as tables, listing, figures, etc.
- Mediate with DM on statistical questions connected to data concerns, which involves arranging data transfers from DM to statistics.
- Guide all biostatistics actions connected to clinical trials as an accountable project statistician.
- You will develop and document analysis database structures such as SAS analysis dataset structures.
- Discuss line for project teams, which involves statisticians and SAS Programmers.
- Contribute to the development of regulations, processes and any other quality systems documents relevant to actions of the biostatistics division.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to an advanced degree level in a statistics or similar field.
- Capable of implementing a variety of evolved statistical practices in assistance of clinical research studies and to analyse, comprehend, and draw conclusions from multifaceted statistical information.
- Able to consult with clinical investigators, comprehend research needs and establish statistical analysis methods.
- Demonstrable experience within relevant industry on clinical research, biostatistics and SAS programming.
- Know-how and comprehension of the statistical principles, ideas, strategies and standards used within clinical research.
- Capable of representing biostatistics in bid defenses.
- Know-how of pertinent guidelines and regulations, such as FDA, EMA, ICH, etc.
- Presentation and communication skills both verbally and in writing.
- Expertise on SAS software with computer literacy.
- Knowledge of CDISC ADaM IG 1.0 or later, define1-0-0.xml and define2-0-0.xml specifications, as well as of CDISC SDTM IG 3.1.3 or later and nQuery Advisor software which would be beneficial.
If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan on email@example.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.