ProClinical is advertising a vacancy for a Biostatistical Programming Manager with a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. This organisation, which prides itself on its international reach, is seeking for the Biostatistical Programming Manager to join their team in Uxbridge.
The Programming Manager will be responsible for overseeing the Functional Services Provider (FSP) and focusing on operational excellence and delivering projects on time within the agreed scope. They will join the Global Statistical Programming team in ensuring projects outsourced to Functional Services Providers are aligned to priorities and meat company timeline, quality, data standards, and compliance expectations.
Job Responsibilities:
- Aligning FSP assignments with company development priorities.
- Providing estimation of 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 Statistician, Product Lead Programmer, and FSP Study Lead Programmer on project priority, timelines, deliverables, quality oversight plans, and data standards.
- Conducting kick-off meetings with FSP staff for each outsourced project.
- Meeting regularly with FSL SLP to assess project progress and helping address project level operational issues.
- Collaborating with company statisticians to develop the Project Delivery Plan for FSP deliverables and implementing the plan.
- Routinely reviewing project documentations such as issue logs and deliverable status.
- 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 company demand review cycles and updating estimates 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 refinement recommendations.
- Monitoring and reporting on FSP performances, including metrics and adherence to service level agreements around quality, compliance, productivity, and timelessness of deliverables.
- Contributing to FSP training material development and providing initial training to FSP.
Skills and Requirements:
- A degree in Computer Science, Statistics, Mathematics, Life Sciences, or other relevant scientific subject.
- 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 successful completion of all study programming activities and providing guidance on technical and process questions.
- Demonstrable experience with working in a globally dispersed team on Phase I-IV clinical trials.
- Advanced experience in SAS analysis and reporting skills, including SAS Base, macro, and SQL.
- Hands-on experience in specifying and implementing SDTM and ADaM data sets and TFLs.
- Able to define and implenet and effective standardisation strategy for a product following the latest CDISC SDTM, ADaM, and defining standards.
- Demonstrable experience with regulatory submission.
- Demonstrable experience with vendor and resource management.
- Familiarity with other programming languages such as R or Python.
- An in-depth knowledge of SAS/Graph and Stat packages.
- A thorough understanding of data compliance checks, such as Pinnacle 21.
- An ability to learn, assimilate, and effectively communicate information to support colleagues, discuss with partners, and advise clients on requirements.
- Strong interpersonal skills, including communication, leadership, relationship management, and influencing.
- Capable of leading interdisciplinary projects and to implement change within a high-performing organisation.
- Demonstrable computer software skills, including MS Office.
- A flexible mindset that is suited to dealing with multiple projects in a timely manner.
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 Harry Williams on +44 203 854 0102 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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