Principal Biostatistician (VAX)

Main responsibilities:

• Support the clinical study design (including concept protocol development), the study setup, conduct and reporting.
• Accountable for all assigned statistical study deliverables: develop statistical sections in protocol (i.e. statistical methodology, sample size calculation, ?); ensure protocol is statistically sound; contribute to randomization specifications and set-up; develop Statistical Analysis Plan; plan and execute statistical data surveillance; perform data analysis; contribute to interpretation of results with the Project Biostatistician; ensure clinical study report statistical integrity and the specific deliverables related to Transparency and Disclosure
• Develop Integrated Analysis Plan for Safety or Immunology Summaries. Conduct related analyses in collaboration with programming and deliver outputs for submission Core Technical Dossier
• Work with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan. Perform and/or coordinate with study programmer the production of statistical analyses and CDISC compliant data package, ready for submission
• Propose, prepare and perform complex exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives and/or in answering Health Authorities questions
• Provide statistical insight into interpretation of results in line with other sponsored studies and competition results. Use strong communication skills to present and explain the methodology chosen and consequences in results interpretation and decisions
• Ensure productive collaborations with other functions in the aligned study team and/or safety monitoring team and in communicating with senior leadership.; Promoting teamwork, quality, operational efficiency, and innovation.
• Represent statistics to participate in scientific or technology working groups or cross function initiatives

About you

You are a passionate leader with following experience and competences who like the challenge and growing into a new environment:

Experience:

• 8+ years' experience in clinical Biostatistics and Programming research, including at least 3-5 years in Vaccines (trial designs, endpoints, statistical methods, ?)
• Experience in acting end to end as Study Biostatistician (ie, non-standard sample size, statistical section of protocol, randomization set-up with vendor, Statistical Analysis Plan, analyses, study report, publication?)
• Experience in leading programmers through some e-submission statistical activities (e.g. ISS, ISE, and/or ISI)
• Experience in performing complex exploratory statistical analyses without written specifications
• Consistent successful experience as a lead on several concurrent studies/projects (programming experience in SAS and R)
• Demonstrate knowledge of CDISC (SDTM/ADaM/SEND) including specifications, P21, define.xml, Reviewers Guide
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Skills:

• Excellent understanding of processes associated with clinical trials, including knowledge of interfaces and interdependencies with other functions
• Demonstrate interpersonal/teamwork in technical and leadership skills
• Strong projects management skills
• Clear ability to organize multiple work assignments to a team and establish priorities
• Understand and able to contribute to resourcing strategy implementation, developing capacities and capabilities
• Eager to learn and explore new territories
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Education:

• PhD or Masters degree in Statistics (preferred), Mathematics or related health sciences or equivalent experience
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Languages:

• English: Highly effective communication, both oral and written.