Albion Rye Associates
*Director, Statistical Programming*
*East Coast, US*
Albion Rye Associates are working in partnership with our client, a global leading Biotech operating within Rare Diseases, in the recruitment of a Director to lead their Statistical Programming function. Reporting to the VP of Biometrics.
You will be responsible for driving excellence across the Programming team, supporting the Biostatistics and Data Management functions, and working closely with other cross-functional teams on a variety of tasks. Providing technical support for ongoing trials, FDA submissions, and development of initiatives. Whilst providing expert-level hands on support and technical leadership to all clinical development and regulatory submissions.
Principal responsibilities will include to:
* Lead statistical programming oversight of outsourced trials
* Participate and provide strategic guidance in study setup/design and initiation procedures
* Manage CROs to meet timelines and deliveries. Ensure that CROs, vendors and internal teams meet the quality standards
* Support the strategic decision-making process involving programming for ongoing clinical trials. Communicate cross-functionally how programming decisions affect other functions
* Write and review the specifications for CDISC (SDTM and ADaM)
* Provide SAS Programming expertise to solve complex issues, interpret SAPs and develop dataset specifications
* Responsible for the creation and accuracy of Regulatory submission data and reports
* Bachelor’s Degree in Statistics or related discipline. Master’s Degree preferred
* Significant Statistical Programming experience in Pharma, Biotech, or CRO with 3-5 years’ management experience
* Strategic leadership experience in a cross-functional team setting with extensive experience in overseeing outsourced models
* Proficient programming skills and experience in CDISC (SDTM and ADaM), industry standards for Regulatory submissions
This role can be based anywhere across the East Coast with a preference to New Jersey, Boston, New York or North Carolina. Other locations will be considered though.
Please get in touch with Erick Semerene, Head of Biometrics Recruitment:
*ALL CONVERSATIONS ARE HELD IN THE STRICTEST CONFIDENCE.*
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