Associate Director of Programming, Modelling and Simulation

A leading pharmaceutical client is searching for an Associate Director of Programming, Modelling and Simulation to join their team in Hatfield. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe.

Job Responsibilities:

• SAS programmer with demonstrable experience contributing to multiple development projects.
• Maintain processes, code and documentation to enable routine transfer of datasets to and from M&S and other necessary associated programming activities.
• Manage study schedule dates of deliverables and priorities in consultation with global head of M&S.
• Maintain project schedule in consultation with global head of M&S.
• Liaise with global head of M&S on outsourcing of the creation of NONMEM datasets.
• Review M&S specs ensuring they follow the latest standard or if applicable follow a previous study within that compound and liaise with the M&S person responsible for the project on any changes required for the specifications.
• Assure planning and timely completion of draft and post lock final SDTM/ADaM datasets by PCU Biostats.
• Review M&S specifications for the purpose of setting up the work order if outsourced.
• Work with NBG (Neurology) and OBG (Oncology) Heads of Programming to assign Lead Programmer if inhouse and ensure QC resource is available.
• Liaise with NBG and OBG with regards to creation of define files for submissions.
• If work is outsourced:
• Kick off meeting to introduce the CRO to the M&S analyst.
• Transfer of data and all relevant docs.
• Weekly meetings with the CRO to answer any questions and liaise with the Head of M&S when the M&S analyst doesn't know the answer.
• Maintain standard NONMEM datasets specifications.
• Create datasets for conducting population PK and PK/PD analyses.
• Knowledge or willingness to learn R would be an advantage.

Skills and Requirements:

• BS or MS in Relevant Field.
• Experience in clinical development statistical programming methods and processes in industry setting required.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

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 contact Emma Adams at +44 203 854 3893 or upload your CV 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.

Proclinical Staffing is an equal opportunity employer.

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