Biostatistical Programming Manager

My client, a multinational biopharmaceutical company based in the UK, are looking to hire a Biostatistical programming manager. This organisation is one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors. This is an exciting opportunity to work with a firm dedicated to innovative and dynamic approaches to the changing workforce landscape. This position will be carried out in a home-based/remote capacity.

The Biostatistical Programming Manager will oversee the execution and quality of projects managed by FSP and ensure that projects are prioritised according to the product strategy.

Job Responsibilities:

• Aligning FSP assignments with the company's development priorities.
• Estimating project resource needs.
• Ensuring FSP programming meets quality, compliance, timeline, and productivity expectations.
• Ensuring FSP adherence to company Policies, SOPs and other controlled documents as per Scope of Work.
• Contributing to FSP training material development and revisions and conducting the initial training to FSP staff.
• Providing guidance to FSP Study Lead Programmers (SLP) on GSP processes, tools, and utilities.
• Contributing to FSP performance metrics data collection and reporting.
• Aligning with Statisticians, Product Lead Programmers, and FSP Study Lead Programmer on project priority, timelines, deliverables, quality oversight plan, and data standards.
• Conducting kick-off meetings with FSP staff for each outsourced project.
• Meeting with FSP SLP to assess project progress and help address project level operational issues.
• Collaborating with the company's statisticians to develop the Project Delivery Plan for FSP deliverables and implement the plan.
• Routinely reviewing project documentations such as issue logs and deliverable status and following up with FSP SLP on concerns or questions.
• Verifying adherence to GSP-wide and product-level standards.
• Representing the company in audits and determining responses to audit questions and findings.
• Maintaining resource estimates for the outsourced project during the company's demand review cycle and updating the estimate as a result of significant milestone or scope changes on the project.
• Capturing specific issues leading to rework or timeline delays during the execution of the project.
• Providing technical consultancy to FSP SLP on functional and product-level processes and tools.
• Advising FSP SLP on study-specific questions for specifications, documentation, and coding.
• Monitoring and reporting on the performance of the FSP operating model and making recommendations for refining the model.
• Monitoring and reporting on FSP performances, including metrics and adherence to service level agreements around quality, compliance, productivity, and timeliness of deliverables.
• Contributing to FSP training material development and providing initial training to FSP.

Skills and Requirements:

• Degree in Computer Science, Statistics, Mathematics, Life Sciences, or another relevant scientific subject.
• An extensive statistical programming experience in biopharmaceutical industry.
• A thorough understanding of clinical trial processes from data collection to analysis reporting.
• An ability to lead programmers in the successful completion of all study programming activities and providing guidance on technical and process questions.
• Experience working in a globally dispersed team on Phase 1-4 clinical trials.
• Advanced SAS analysis and reporting skills, including SAS Base, macro, and SQL.
• Hands-on experience in specifying and implementing SDTM, ADaM data sets, and TFLs.
• Ability to define and implement an effective standardization strategy for a product following the latest CDISC SDTM, ADaM, and define standards.
• Regulatory submission experience.
• Vendor and resource management experience.
• Familiarity with other programming languages such as R or Python.
• In-depth knowledge of SAS/Graph and Stat packages.
• 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.

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