Senior Biostatistician – 12 Months – Home Working / Berkshire
Biopharmaceutical, Clinical Research, Statistical Sciences, SAS Programming
Our client, a global biopharmaceutical leader, is looking to add to their highly skilled Statistical Sciences team in Berkshire with a contractor for 12 months. This company transform the lives of people living with severe diseases, particularly in the areas of the central nervous system and immunology. As the world moves towards tailored medicines and treatment, this organisation is at the forefront of translational medicine and target discovery.
As a Senior Biostatistician you will be fully responsible as the Biostatistician Lead for one or more individual clinical studies within a clinical program or across multiple clinical programs. You will provide statistical input to clinical studies, including input into the study design through statistical analysis and reporting. This person will also be involved in the statistical deliverables for a submission.
*Responsible for providing appropriate statistical oversight of studies, where the lead biostatistician role is outsourced to an external CRO or other vendor
*Exploratory statistical analysis for lifecycle management activities of development compounds
*Collaborate effectively with cross-functional colleagues and other experienced biostatisticians, especially for all aspects related to the clinical development plan and regulatory submission strategy
*Participating in the protocol summary development and input into the study design, efficacy and safety parameters and the planned statistical analyses.
*Responds to the request for the randomization schedule. Interacts appropriately with the vendor if this is not delegated to an external partner biostatistician
*Reviews data management related documents
*Authors the Statistical Analysis Plan (SAP) or reviews and approves the SAP if prepared by an external partner biostatistician.
*Coordinates with other internal or external biostatisticians and statistical programmers to prepare the statistical analyses. Communicates and coordinates all statistical activities with external partner biostatisticians.
*Participates in data review/evaluation meetings and other study-related meetings and activities.
*Understands the regulatory requirements related to design and analysis of studies.
*Bachelor’s degree in statistics, programming, computer science or a related discipline.
*5+ years in biostatistics within the Biotechnology and/or Pharmaceutical Industry (including CRO’s)
*Experience in all phases of clinical studies (in particular phases II-III)
*Sound knowledge of the ICH guidelines
*Good knowledge in clinical related SAS and R Programming
*Experience with sample size software
*Able to explain statistics in a non-technical manner to non-statisticians.
*Able to propose and defend alternative study designs and statistical analyses.
*We would like a keen learner who shows an active participation toward learning new statistical concepts, and the relevant aspects of the disease area of the related programs.
*Able to work in a multicultural global environment.
It would be great to hear from you if you are interested in a new challenge for the next 12 months. The hourly rate will be competitive and we will support you if you have not held a contract position before. Please contact Jade on +44 121 616 3472 for more information and an informal discussion.
Keywords: Biopharmaceutical, Clinical Research, Statistical Sciences, Biostatistician, Statistical Programming, Berkshire, Slough
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
Job Reference: JPSB2509_1537870985
Broadcast As: 184
Salary Currency: GBP
Salary per: Annum
Job Type: Full Time
Job Term: Permanent
Job Industry: Pharmaceutical
Job Specialism: Biometrics
Recruitment Consultant: Jade Page