Our client, a consultancy serving Biopharma, Pharma, Diagnostics and Medical Device, Healthcare and Food organisations is expanding its Statistical operations and it is opening a new position as Biostatistician.
The organisation has a network of international office, while this role will be based in Dublin city centre. This is a superb opportunity to get superb industry experience with the prospect of international opportunities on the horizon.
As biostatistician, you will work with the principal statistician(s) to manage the relevant statistics of clinical trials as necessary, design studies, devise analysis plan, program data files and outputs, implement analysis plan and report and publish findings. The position described is for a highly motivated, hard-working and professional biostatistician who can work closely with other statisticians, programmers, data scientists, data managers, medical writers and clinical experts. Under the supervision of the principal statistician, you will perform technical work associated with a wide variety of analytical data. You will work closely with the Data Management team to interrogate databases for the purpose of creating analytic files, performing quality control and data cleaning and managing data.
Primary responsibilities will include:
Study Design and Setup
• Review and understanding of all source materials for the study, technical and non-technical.
• Review and/or drafting of the Study design and Sample size Calculation
• Drafting of the Statistical Sections of the study protocol
Statistical Analysis Planning and Programming
• Development of the statistical analysis plan (SAP)
• Review and approval of database, including dataset structure and dataset mapping, against SAP and TFLs
• Blind dataset testing
• Programming of all tables for the Statistical Analysis
• Execution of SAP and generation of all tables as outlined in the approved SAP.
• Submission of tables for internal review
• Delivery of final TFLs
Statistical Activities Management
• Input to communication plan, ensure progress with respect to quality and timelines, prepare and/or participate to regular internal and external meetings.
• Data Validation - Review of data as per Data Validation Plan, generation and resolution of queries.
• Development of ADAM and SDTM datasets.
• Data Coding - Includes: Development and use of Data coding conventions (MedDRA, WHO DD and related coding), review of auto coded terms, manual coding if necessary, generate queries and follow-up with resolution to ensure classification, if necessary.
• External Data Handling and Data Transfer - Includes: Development of the Data Transfer Plan, Perform data extract, Completion of the Data Transfer Check List, Development of the statistical sections of the Data management Report.
Skills, Abilities and Experience required:
• A Master’s degree in biostatistics or statistics or equivalent.
• 1+ years of experience in managing, analysing, and reporting the statistical outputs of clinical trials.
• 1+ year experience as biostatistician or programmer in the pharmaceutical industry or a Clinical Research Organization.
• Knowledge of GCP and ICH guidelines and CDASH/CDISC data standards.
• Exceptional communication and management skills and proven ability to communicate technical information to both technical and non-technical staff/clients.
• Strong organizational skills and computer skills.
• Proficient in R and SAS.
Contact Brian Christensen on 01 6854747 or submit your CV to firstname.lastname@example.org for immediate consideration
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747