Summary of Position

Oversees data analysis activities in support of clinical trials and regulatory submissions. Provides technical input to study designs and product development plans. Responsible for the overall quality of statistical design, programming, analysis and data reporting. Represents the company in interactions with outside statistical and data management service providers and participates in discussions with regulatory agencies. Critical member of cross functional product development teams.

Essential Functions

  • Provides primary statistical input for clinical study designs
  • Provides strategic guidance and technical input into product development and regulatory plans
  • Leads development of processes and infrastructure for biometrics, data management and statistical analysis
  • Directs development of statistical analysis plans and reviews statistical programming
  • Ensures timely and accurate delivery of clinical study data analysis results
  • Interprets clinical trial data and contributes to preparation of clinical manuscripts and regulatory submission documents

Job Requirements (Essential knowledge, skills and attributes)

  • PhD in biostatistics or related field, MS with significant industry experience
  • Technically proficient with SAS programming of complex statistical analyses
  • Detailed knowledge of regulatory aspects of statistical design
  • At least 3 years of prior experience working for biotech, pharma or CRO
  • Experience interacting with regulatory agencies highly desirable
  • Experience with vaccines and/or analysis of cellular immune responses highly desirable
  • Excellent English language and interpersonal skills
  • History of successful participation within an interdisciplinary team

Altimmune is an equal opportunity employer that values diversity

Apply now

Email your cover letter and resume or CV to:

hr@altimmune.com

Please reference Position Req#16-101

Posted on September 14, 2016

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