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Principal Biostatistician
Location
Czechia
Posted
9 days ago
Salary
0
Seniority
Lead
Job Description
Principal Biostatistician
ERGOMED
• Maintains responsibility for all assigned duties within a clinical study, this may include: Act as the study lead for multiple studies, clinical programs, and/or large/complex studies with responsibility for all biostatistics related activities. • Support the review and development of clinical programs; may contribute to complex methods and analysis sections of protocols as well as support the review of design; able to provide feedback regarding issues or improvements to initial proposed designs. • May involve oversight of the statistical programming activities. • Ensuring that work is performed on time. • Ensuring all content created/reviewed is appropriate, valid, and relevant to the study and of high quality. • Provide review and oversight to statistical output created by other members of the biostatistics department • Review protocols, synopses, and other statistical documents for a study and provide feedback and consult. • Research, or otherwise support, trial design and consultative activities • Review relevant content from other functional areas (e.g., Case Report Forms) on behalf of the biostatistics team • Write summaries of findings and results to be included as part of study reports such as for interim analyses or the final CSR. • Writing or reviewing some, or all, of the Statistical Analysis Plan and corresponding output shells • Providing relevant specifications/guidance for complex and/or pivotal outputs • Works with other study team members (both internal and external) to represent the needs and input of the statistical components of the study • Reviewing output (TLFs, SDTM and ADaM datasets, SDTM and ADaM specifications) developed by statistical programmers and/or other statisticians for quality, validity, and appropriateness • Provides mentoring and support to more junior statisticians • Represent the function in internal and external meetings for assigned studies. • Represent the function in audits of study activity. • Represent the function in bid defenses and other sales related activities.
Job Requirements
- Master’s degree (or Higher) in biostatistics, statistics, mathematics or other related disciplines
- General understanding and application of biostatistics in clinical trials
- Strong related experience working in a Contract Research Organization
- Proficiency in one or more statistical programming language (SAS and R preferred)
Benefits
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
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