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Project Statistician
Ref No.: 18-13637
Location: Cambridge, Massachusetts
Start Date / End Date: 10/29/2018 to 04/26/2019


Responsibility
• Represent the statistics function in support of Oncology TAU related activities.
• Provide statistical input to feasibility assessments, development and submission plans, and in support of regulatory submissions.
• Provide statistical support with minimal supervision in the development and review of the statistical analysis plan, study report, and other analytical documents, ensuring accurate and statistically valid deliverables.
• Implement project level database (including derived database), analysis and reporting standards. Provide suggestions to achieve high quality databases and specifications by working with Data Management and Programming at project level.
• Plan and direct study-level analysis and reporting activities (eg, tables, listings, graphs) including review of work by programmers.
• Identify study-level vendor requirements and participate in the evaluation/selection of analytical vendors. Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
• Anticipate and communicate study level resource and quality issues that may impact deliverables or timelines. Propose and implement solutions. Escalate issues to management as appropriate.
• Consider and evaluate alternative analysis methodology and data presentation techniques.

EDUCATION, EXPERIENCE AND SKILLS:

• Generally requires PhD in statistics or biostatistics with at least 4 years of relevant experience or MS in statistics or biostatistics with at least 6 years of relevant experience. For statisticians with exceptional talent who have demonstrated core capabilities of a Principal Statistician, 3 years of pharmaceutical industry experiences with a PhD in statistics or biostatistics may be considered.
• Experience with advanced study design or at least one NDA/CTDs or other global regulatory submissions.
• Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics.
• Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.
• Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
• Good knowledge of statistical programming languages (including SAS), software, techniques, and processes. Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft Office products).
• Excellent oral and written communications skills.
• Strong project management skills.
• Strong collaborative skills and ability to work with a cross-functional team.