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About the Role: The Sr. Statistician is a member of the clinical team and is responsible for statistical input, including SAS programming, to clinical studies. The Sr. Statistician must ensure that activities and processes performed are conducted according to company requirements. This position works closely with other team members.
Responsibilities: ·Act as a statistical contact across the business ·Interact with Data Management personnel as necessary to ensure that the data are in usable format; perform statistical diagnostics prior to database locking ·Prepare and coordinate for blinded data review meetings prior to database lock ·Perform ad hoc review of data and analyses following unblinding, as required ·Ensure that appropriate programs are developed for reporting clinical studies ·Perform statistical quality control review and program validation for studies ·Interact with report writers in the production of clinical study reports and other documents containing statistical information. Review draft documents ·Provide statistical input into clinical trial protocols ·Input into the development of departmental processes, including standard working practices and operating procedures ·Work and ensure adherence to CDISC standards for applicable clinical trial reporting ·Respond to regulatory questions regarding submissions ·Act as a deputy for the Head of Biometrics where experience allows ·Can sign on behalf of the Head of Biometrics where experience allows
Requirements: ·Master's degree in Statistics or a subject with a major statistical component with strong 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 Guidelines ·Proficient in the use of computers and especially the SAS system ·Ability to perform and interpret statistical analyses of clinical data ·Good understanding of clinical data, including data quality issues ·Able to work in a fast-paced, team-oriented environment ·Possess excellent interpersonal and communication skills (written and verbal) ·Strong attention to detail with a view to bringing studies to a quality conclusion ·Flexible, positive, creative thinker, good communicator ·Able to work without close supervision ·Well-developed time management skills