We are recruiting for a Biostatistician for a multinational pharmaceutical, they are a European leader and one of the largest globally in their field.
The role: Participates in the strategic discussion and study design for new indications/studies. Coordinates statistical analysis plans, and reporting (tables, listings, and figures) with standards to support international submissions that can be assembled efficiently with all studies acceptable to international regulatory agencies. Provides biometric support for investigator led studies, pharmacoeconomic, and post marketing studies.
Location: Remote working in Republic of Ireland
Salary: Excellent salary, bonus and benefits available.
- Serves as principal biometry contact to the clinical development department, providing inputs into clinical trial design and execution, coordinating statistical analysis, reporting, and interpreting the clinical trial results.
- Analyse clinical trial data, producing accurate results representing the outcome of the trial. Validates statistical output. Interprets and clearly communicates statistical results and concepts.
- Supervises the biostatistics work provided by CROs and independent consultants.
- Reviews data management documents including, but not limited to, CRFs, data management plan, database specifications, performs user acceptance testing of databases and assists in protocol deviation reviews and edit checks.
- Review SDTM and ADAM data specifications
- Writes Statistical Analysis Plans; prepares for blinded data review meeting
- Writes statistical analysis section of protocol and clinical study reports.
- Oversees the process of randomization schedule generation.
- Provides input into statistical SOPs and general standardization efforts within the clinical development department (e.g. statistical methodology standards, standard data presentations, standard CRFs).
- Supports Regulatory Authority meetings (e.g. pre IND meetings; Represents company at FDA or other agency with regard to methodological issues and support of results).
- May participate as unblinded participant in a safety review committee for a specific clinical trial
Your knowledge and experience:
- Excellent knowledge of statistical methodology, including experimental design, linear models, categorical data techniques, nonparametric statistics, and survival analysis.
- Excellent knowledge of FDA guidelines related to SDTM/ADAM data specification, trial design, analysis, and reporting.
- Solid skills in computer programming (especially SAS). Strong communication and interpersonal skills.
- Excellent writing ability to author reports that will be acceptable to regulatory agencies. Strong analytical, problem-solving, and active learning skills.
- Strong organizational, documentation, and information gathering skills.
- Ability to work in multiple therapeutic indications and able to handle multiple projects across these therapeutic areas.
- Normally receives little instruction on day-to-day work and general instructions given on new assignments.
- Master's degree or PhD in statistics or related field. Typically requires 5 years of pharmaceutical experience. (If PhD in statistics, equivalency is 2 years of pharmaceutical experience.)
- Determines methods and procedures on new assignments and may coordinate activities of other employees.
- May act as a team lead.
If you are interested in this Biostatistician's position please contact either my colleague Sarah Savage or myself through LinkedIn or directly to arrange a confidential follow up call: 01 645 5222, Mobile: 087 621 4254, email@example.com firstname.lastname@example.org