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Sr. BioStatistician
Ref No.: 18-12634
Location: Waltham, Massachusetts
Start Date / End Date: 10/01/2018 to 06/21/2019
The candidate will work in a multi-functional team in Medical Affairs to provide statistical support to phase 4 clinical studies, registry studies, post-hoc analyses, publications, and retrospective chart review studies for rare bleeding disorders.

The candidate will work in a multi-functional team in Medical Affairs to provide statistical support to phase 4 clinical studies, registry studies, post-hoc analyses, publications, and retrospective chart review studies for rare bleeding disorders. The successful candidate must have excellent statistical knowledge and strong SAS programming skills. Past experiences with protocol development, SAP, SDTM/ADaM, TLF, and CSR are required. Must be an independent thinker with good communication and problem solving skills. Must be experienced in developing valid research hypothesis, testing its validity, and sample size calculation. The candidate will serve as project lead on multiple projects and collaborate with statistical programmers for statistical deliverables. Responsible for establishing consensus on analysis approaches, managing timeline and quality of statistical outputs, and interpreting the results. Past experience in CRO oversight is a plus.

Qualifications:
• MS with 6 years or PhD with 4 years working experience working on clinical trials in the pharmaceutical industry and/or biotechnology industry.
• Thorough understanding of statistical principles with the ability to practice and implement them. Ability to provide solutions to a variety of technical problems of moderate scope and complexity.
• Proficiency and experience in SAS programming, and knowledge of SAS procedures and other statistical software.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Effective communicator: able to explain methodology and consequences of decisions in Client terms.
• Effective team player: willingness to go the extra distance to get results, meet deadlines, etc.
• Able to be flexible when priorities change. Able to deal with ambiguity.
• Knowledge of medical/biological terminology and clinical practice in hemophilia is preferred.

Education: • MS or PhD in Biostatistics/Statistics or equivalent
Skill Required / Desired Amount of Experience
SAS Programming Required 4 Years
Knowledge of drug development process and clinical trials Required 4 Years
Knowledge of drug submission requirements, relevant ICH and FDA/EMEA guidelines, CDISC standards. Required 4 Years
Linux/UNIX Required 4 Years