The Role:You will Support Regulatory processes and systems in the production and archiving of Regulatory Submissions supported by the Submission Operations team. Key Responsibilities:Creation, formatting...
Expert StatisticianLocation: Cambridge (Home-based option)Permanent, full-timeSalry: 45K-50K per annum
Our Client is a world leading Pharma companies looking for a professional and talented Senior Statistician to join their clinical team.Tha candidate will responsible for statistical input, including SAS programming, to clinical studies and ensure that activities and processes performed are conducted according to company requirements.
Interact with Data Management personnel as necessary to ensure that the data are in usable format; perform statistical diagnostics prior to database lockingPerform ad hoc review of data and analyses following unblinding, as requiredEnsure that appropriate programs are developed for reporting clinical studiesPerform statistical quality control review and program validation for studiesInteract with report writers in the production of clinical study reports and other documents containing statistical information. Provide statistical input into clinical trial protocolsInput into the development of departmental processes, including standard working practices and operating proceduresWork and ensure adherence to CDISC standards for applicable clinical trial reportingAct as a deputy for the Head of Biometrics where experience allows
Expeirence & Skills:
Master's degree in Statistics or a subject with a major statistical component with previous experience in similar role (production of statistical analysis plans and statistical reporting/generating TFLs are essential for this role)Good knowledge of applicable regulatory requirements and guidelines, e.g. ICH GuidelinesProficient in the use of computers and especially the SAS systemAbility to perform and interpret statistical analyses of clinical dataAble to work in a fast-paced, team-oriented environmentPossess excellent interpersonal and communication skills (written and verbal)Strong attention to detail with a view to bringing studies to a quality conclusionFlexible, positive, creative thinker, good communicator
The client's vision is to make a positive difference in the lives of patients. A very innovative, collaborative and accountable company who have the well-being of their workforce. Competitive Benefits and strong Career Program
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.