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Director, Statistical Programming

Employer
Albion Rye Associates
Location
East Coast - Remote Work is considered
Salary
Salary in excess of $180,000 + benefits Depending on experience
Start date
20 Apr 2021
Closing date
20 May 2021

Job Details

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

Your Background:

  • 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:

Email: erick.semerene@albionryeassociates.com

ALL CONVERSATIONS ARE HELD IN THE STRICTEST CONFIDENCE.

Company

At Albion Rye Associates, we create a bespoke recruitment process that is thorough, professional, personable – and most importantly, tailored to exactly to what you need.

We have a clear focus on collaboration and communication. We are solutions-led and know from vast experience that for successful outcomes to be reached, we don’t just work for our clients and candidates – we work with them.

Our valued clients and candidates have the highest of standards and expectations. We are exactly the same. If we weren’t, they wouldn’t want to work alongside us. We ensure that every client and candidate receives the made-to-measure, personalised recruitment service that they want, need, and deserve through building long-term working relationships.

Company info
Website
Location
CoTribe Offices – Raven House
29 Linkfield Lane
Redhill
Surrey
RH1 1SS
United Kingdom

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