Primary job role

The Sr. Biostatistician Consultant will provide Biostatistical support and work on key client deliverables involving designing and analyzing clinical trials. The incumbent should be able to work independently implementing and executing the programming and project standard to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis.

Responsibilities

• 0 Contribute to clinical development plan preparation

• 0 Review of study protocol and preparation of statistical methodologies

• 0 Manage the generation of analysis databases, and analyses for medium to high complexity clinical trial projects including ISS, ISE, and electronic submissions

• 0 Assist in the development of new processes for efficient analysis production

• 0 Provide leadership and guidance for solutions in data management, analysis and reporting related issues

• 0 Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials

• 0 Present Biostatistics function at conferences, external meetings, bid defense, etc.

• 0 Mentor junior level Biostatisticians

Requirements

• 0 MS degree in Biostatistics/Statistics with 10 years of pharmaceutical clinical trial experience, or Ph.D. degree in Biostatistics/Statistics with 5+ years of pharmaceutical clinical trial experience

• 0 Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA

• 0 Programming skills in SAS and working knowledge of software such as nQuery, East, etc. to create ISS, Shells, TFLs, and Ad Hoc Analysis.

• 0 Excellent analytical, written, and oral communication skills