Title: Biostatistician
Location: Middle-East
Qualifications and Experience:
- 2 years of related biostatistics experience in either a pharmaceutical or CRO environment or other relatable statistical experience
- Master’s degree in Biostatistics, Statistics
- Knowledge of ICH guidelines and regulatory requirements as they relate to biostatistics activities, SAS programming
- Experience providing ability to explain complex statistical concepts to other project team members
- CDISC SDTM and ADaM dataset mapping experience
- Therapeutic experience in transplantation, autoimmune diseases, and kidney and liver disease
The main responsibilities:
- Act as primary statistical contact for internal and external project team members.
- Communicate and work with Biostatistics management to maintain the project budget and timelines.
- Review case report forms (CRFs) and completion instructions
- Give input to database design and data edit considerations necessary to collect and clean data
- Develop, or assist in the development of, Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol
- Develop program specifications – SDTM and ADaM dataset specifications and mock tables, listings and figures (TLFs) – needed to perform the analysis defined in the IAP/SAP
- Perform the statistical analysis by independently programming derived datasets and TLFs and validate the developer’s corresponding programs per department SOPs
- Develop or review statistical methods and results sections of statistical reports, clinical study reports (CSRs), or publications
- Assist in planning and designing clinical studies, including:
- overall study design development
- outcome / endpoint determination
- power analysis / sample size estimation reports
- randomization and blinding procedures development
- statistical methods section development in the protocol
- Develop, or assist in the development of, Randomization Plans and randomization programs or lists
- Carry out all activities according to CTI SOPs and project-specific conventions within the framework of Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines
- Rely on instructions and Biostatistics SOPs to ensure timely, standard, and quality deliverables to customers
- Maintains accurate records of all work performed and ensure all relevant statistics documents are filed in the eTMF per the project-specific eTMF Plan
- Provide input to and participate in departmental meetings
If interested, please send your CV to jobs@clinart.net mentioning the Job Title in the subject
