Job Description

We are hiring a Biostatistics Consultant on a contract basis. This is remote position.

The Biostatistics Consultant acts as statistical study lead; provides technical input and biostatistical support on the design and conduct of clinical studies; participates in the evaluation, interpretation, and reporting of study results; performs statistical analyses; provides timely support to the project teams on all statistical matters.

Responsibilities

• Lead in study level tasks, ensuring statistical integrity; contribute strategically to the supporting projects from statistics perspective.
• Contribute to study level tasks from statistics perspective, including study design and sample size determination, protocol statistics section, SAP and DMC charter; Review study randomization files; Develop TFL shell and specification; Review CRFs and other study documentations; Active participation in study related meetings
• Works collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting
• Independently conduct analyses suggested by the data; Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results
• Contribute to developing standards and research in advanced statistical methodologies
• Review regulatory documents or scientific publications

Requirements

• PhD in Statistics or Biostatistics with a minimum of 3 years (min 6 years for Master's degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry
• Experienced in NDA / BLA / MAA activities as a contributor from statistics perspective and direct involvement in regulatory interaction is preferred
• Experienced as or is capable to act as study lead statistician and contribute to strategy discussion in cross functional settings
• Experienced in study level work including authoring SAP and TFL specification
• Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance
• Solid understanding of mathematical and statistical principles
• Detailed-oriented with organization, problem solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according to company timeline
• Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies
  

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