Senior Manager/Associate Director

Proclinical is currently seeking a Senior Manager/Associate Director of Biostatistics and Statistical Programming for a global commercial-stage biopharmaceutical company. Successful candidate will provide experienced and independent statistical and programming leadership in support of the company's clinical development, regulatory submission, and publication activities.

Job Responsibilities

• Serve as the lead statistician on clinical studies or regulatory submissions, accountable for all statistical/programming aspects.
• Provide statistical programming support to clinical studies or integrated analyses, including independent validation of key statistical outputs and exploratory analyses in support of publications and ad hoc requests.
• Develop and maintain standard macros and programs used in creating datasets and TFLs.
• Collaborate with Data Management to ensure high quality and timely data.
• Ensure compliance of data packages to regulatory requirements and industry standards.
• Provide statistical representation at regulatory or other external meetings.

Skills and Requirements

• MS/MPH or PhD/DrPH in statistics, biostatistics, or epidemiology.
• 7+ years (if MS/MPH) or 5+ years (if PhD/DrPH) of experience as a statistician and/or statistical programmer in the pharmaceutical, biotech, or CRO industry.
• In-depth knowledge of Phases I-IV of the drug development process and some experience working on NDAs/BLAs.
• Highly proficient in SAS programming.
• Experience with other statistical computing software.
• Experienced in FDA and industry data standards, especially CDISC SDTM/ADaM standards.

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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