Associate Director, Biostatistics

Proclinical, in support of our client, are seeking an individual to fill the role of Associate Director of Biostatistics, based in Boston, MA. The successful candidate will assume responsibilities for statistical activities in support of clinical trials.

Responsibilities

• Represent biostatistics at cross-functional team meetings to drive clinical development of drug candidate and provides input on clinical development plans.
• Collaborate with Clinical Development, Regulatory and Clinical Operations spaces to design clinical trials.
• Write statistical sections of clinical trial protocols, while consulting with experts.
• Contribute to or prepare statistical analysis plans.
• Work 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.
• Contribute to clinical study reports and other regulatory documents.
• Attend meetings with regulators, Key Opinion Leaders, partners, and other stakeholders.
• Contribute to scientific articles, summarizing data collected in clinical trials.
• Participate in other activities and meetings as needed.
• Consult with Research and Preclinical colleagues on statistical questions in their work.
• Manage CRO statistical and programming support.

Skills And Qualifications

• PhD in relevant scientific/statistical field an 7+ years of pharmaceutical biostatistics experience; or MS with at least 10 years' relevant experience.
• Excellent written, verbal, and interpersonal communication skills.
• Experience programming in SAS.
• Experience in clinical development through Phase 3 (NDA submission).
• Understanding of ICH GCP as well as general knowledge of industry practices and standards.
• Proficiency in R programming language and other statistical software, including EAST.
• Experience with CDISC, including SDTM, ADaM, CDASH.
• Experience designing and conducting adaptive trials.
• Interest in and basic understanding of biology and biological processes, including RNAi.

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) 9293881650 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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