Senior Biostatistician

Senior Biostatistician

Biocartis

Mechelen, Belgium

The Senior (SR) Biostatistician leads and manages overall statistical analysis and operations for multiple, complex global clinical trials/projects with a primary focus on CE-IVD, US FDA submissions and other global registrations. He/She will provide statistical expertise in analytical and clinical validation study design, write statistical analysis plans and reports, perform statistical analysis and programming in alignment with Strategic & CDx partnerships and Biocartis business strategies and goals.

He/She will also assist in the preparation of experimental design and quality control release strategies.

The Sr Biostatistician establishes best practices, efficiency improvements, and transfer clinical development knowledge across project teams. The Sr Biostatistician may also serve as mentor to other Biostatisticians.

Accountabilities:

  • Apply knowledge of statistics, statistical programming, and regulations to IVD diagnostic development projects;
  • Design and review of analytical validation and clinical protocols, including preparation of statistical sections, statistical analysis plan (SAP), sample size calculations, randomization, and study design;
  • Provide statistical guidance in development of analytical validation protocols, clinical studies and in design of individual studies as part of multi-disciplinary team; responsible for statistical input to protocol;
  • Prepare and review statistical analysis plans (including protocols, shell tables, listings, and figures, analytical and clinical study reports);
  • Prepare and review programming specifications used in creating derived datasets, tables, listings, and figures;
  • Perform efficacy and safety analyses for clinical trials data and participate in validation and quality checks for statistical output;
  • Implement and support CDISC (both SDTM and ADaM) and other regulatory standards;
  • Review CRFs, database specifications, and database validation checks;
  • Statistical programming and related activities for the presentation and analysis of clinical trial data;
  • Participates in preparation of the clinical sections of regulatory submissions packages and assists in responding to requests from the regulator regarding the clinical study;
  • Shares his/her expertise with others and is able to coach and mentor other members of the Biostats team;
  • Performs other tasks, duties or support other roles as needed.

Profile requirements:

  • MA or MSc in (Bio)Statistics or a related discipline, PhD would preferred, preferably with a medical statistics component or equivalent through experience;
  • 5-10 years’ experience, supporting clinical trials in the IVD Diagnostic, Pharmaceutical or Biotechnology industry;
  • Good understanding of medical statistics, study design and regulatory reporting;
  • Good understanding of molecular detection techniques (PCR) and oncology clinical trials;
  • Good understanding of design and development processes;
  • Affinity with molecular detection techniques (PCR) will be highly appreciated;
  • Knowledge of basic statistical concepts in clinical trials;
  • Excellent technical writing and documentation skills;
  • Knowledge of international regulatory and quality guidelines for clinical laboratory methods (ISO, FDA, CLSI,);
  • GLP and GMP working knowledge;
  • Planning & organization - Team/project planning & stakeholder management, plans ahead, monitors results and adapts plans; Self-starter & significant degree of autonomy; Clear sense of urgency and able to manage multiple projects simultaneously;
  • Adaptability to change - Supporting & facilitating change: enables and shapes change, helps others to understand the need for change and adapt to it;
  • Resilience - Continues to perform effectively under time pressure and in the face of disappointment, adversity and opposition; Able to work under pressure and have a flexible approach;
  • Communication & influencing - Communicates with influence:influences and convinces internal and external stakeholders; empathic listener; Well-developed verbal and written communication skills; Ability to influence others to achieve positive results and collaboration;
  • Analytical thinking - Performs complex data analysis with impact on the company, makes evidence-based judgements that guide organizational decisions;
  • Coaching & development - Provides constructive feedback, takes an exemplary role towards learning, guiding and mentoring colleagues;
  • Exhibits strategic and critical thinking skills;
  • Willing to travel internationally.

Languages:

  • Fluent in English, both written and spoken.

PC skills:

  • Experience with writing scripts in R (including version control – Git);
  • MS Office (Word, Excel, Powerpoint, Outlook).

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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