Senior Manager, Biostatistics

The Manager/Senior Manager, Biostatistics is responsible for statistical activities in support of clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. Successful candidate will collaborate with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials.

Responsibilities

• Write the statistical sections of clinical trial protocols.
• Contribute to or prepares statistical analysis plans.
• Collaborate with Data management, Clinical Development, and Clinical Operations on design of eCRFs.
• Provide statistical guidance on conduct of ongoing trials.
• Collaborate with Statistical Programmers on summary and analysis of trial data. Author ADS and ad hoc analysis specifications.
• Contribute to clinical study reports and other regulatory documents.
• Contribute to scientific articles, summarizing data collected during trials.
• Participate in activities and meetings to support Biostatistics and the Development Teams.
• Consult with Research and Preclinical colleagues on statistical questions.
• Manage CRO statistical and programming support.

Skills and Qualifications

• PhD in Biostatistics, Statistics, or equivalent with 5+ years pharmaceutical biostatistics experience; or MS with 8+ years relevant experience.
• Experience programming in SAS, R language and other statistical software.
• Interest in and basic understanding of biology and biological processes, including RNA.

• Experience in clinical development through Phase 3 (NDA Submission).
• Understanding of ICH GCP as well as general knowledge of industry practices and standards.
• Experience with CDISC, including SDTM, ADaM, CDASH.
• Experience interacting with FDA and international regulatory authorities.
• Experience in drug development for rare genetic diseases.
• Experience designing and conducting adaptive trials.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Junis Citozi at (+1) 929-388-1650 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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