Sr Biostatistician II

  • Cambridge, MA
  • Full-time
  • Department: Research & Development
  • Region: US

Job Description

The Senior Biostatistician II  is responsible for providing statistical support as assigned. He/She act as Biostats SMT statistician, provides statistical input in the scientific discussion, participates in the development of study protocols including participation in study design discussions. He/She also reviews study setup activities including but not limited to randomization, CRFs and data edits and may serve as primary biostatistician at project level. He/she develops statistical analysis plans including data and report specifications, performs statistical analyses, interprets statistical results, and co-authors clinical study reports. He/she contributes to internal decision making, publications of the clinical data, and integrated summaries for regulatory submissions. Keeps up to date on current methodology research and conducts methodology research driven by project need.

Principal Accountabilities:
1. Represents the statistics function in SMTs to provide statistical expertise and operational insight
2. Provides statistical support in the development of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
3. Analyzes and communicates study level resource and quality issues that may impact deliverables or timelines. Propose and implement solutions. Escalate issues to management as appropriate.
4. Explores alternative analysis methodology and data presentation techniques. Performs modelling and simulations to identify solutions for complex statistical issues.
5. Supports the development and implementation of ADS standards. Participates in process improvement initiatives.

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Qualifications

  • PhD in Statistics/Biostatistics or equivalent with a minimum of 2-3 years of relevant experiences or Master degree in Statistics/Biostatistics or equivalent with a minimum of 3-4 years of  relevant experiences
  • Thorough understanding of statistical principles and clinical trial methodology with the ability to practice and implement them.
  • Ability to provide solutions to a variety of technical problems of moderate scope and complexity.
  • Working knowledge of medical/biological terminology and clinical trial designs
  • Proficient in statistical programming languages and software, including SAS, and computing tools for modelling and simulations
  • Working knowledge of regulatory guidelines relating to statistical analysis, study reports and statistical components of regulatory submissions.
  • Attention to details
  • General project management skills
  • Effective oral and written communications
  • Good collaborative skills and ability to work with a cross-functional team

Additional Information

The Senior Biostatistician II is responsible for providing statistical support as assigned. He/She act as Biostats SMT statistician, provides statistical input in the scientific discussion, participates in the development of study protocols including participation in study design discussions.

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