Associate Director of Statistical Programming

Proclinical, in support of our client, are seeking an individual to fill the role of Associate Director of Statistical Programming, based in Boston, MA. The successful candidate will work closely with the Biostatistics and Clinical teams, overseeing vendors and working with internal resources to provide statistical programming support.

Responsibilities

• Serve as the lead statistical programmer for statistical activities across all clinical studies.
• Work closely with Biostatistics, Data Management and Clinical teams on statistical analysis of data.
• Ensure that data collected will meet the objectives and the requirements of statistical analyses.
• Review statistical analysis plans and shells for tables, figures and listings.
• Provide technical and project management leadership for internal statistical programmers.
• Manage CROs to analyze and report complex data in Tables, Listings, and Figures, and for relevant electronic submissions.
• Provide responses to regulatory requests.
• Support publication preparation.
• Oversee CROs for outsourced statistical programming activities. Lead QC activities for key results.
• Provide technical and project management leadership in SAS programs and applications.
• Coach, mentor, and manage the performance of direct reports and junior programmers.

Skills And Qualifications

• BS/MS in biostatistics/epidemiology or a related field with 10/12+ years of experience.
• In-depth knowledge of FDA, EMA and ICH regulations and guidelines.
• Experience with BLAs, MAAs and other regulatory submissions.
• Strong written, verbal, and interpersonal communication skills.

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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