Principal Biostatistician

🔥 17 minutes ago

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• 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.

🎯 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