Biostatistical Programming Manager
An exciting opportunity has arisen for a Biostatistical Programming Manager at a leading biopharmaceutical organisation with extensive experience in discovering, developing, and manufacturing innovative human therapeutics. Based in Uxbridge, this opening is an exciting opportunity for applicants seeking their next career step within Statistical Programming and work with a truly global company with over 17,000 employees worldwide.
The Biostatistical Programming Manager will be part of a Global Statistical Programming team, ensuring that projects outsourced to Functional Services Providers (FSP) are aligned to priorities and meet company timelines, quality and data standards, and compliance expectations.
- Aligning Functional Services Provider (FSP) assignments with Company 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 Statistician, Product Lead Programmer, and FSP Study Lead Programmer (SLP) on project priority, timelines, deliverables, quality oversight plan, and data standards.
- Conducting kick-off meetings with FSP staff for each outsourced project.
- Regularly meeting with FSP SLP to assess project progress and help address project level operational issues.
- Collaborating with Company Statistician 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 throughout the project and shortly before key milestones.
- Representing the company in audits and determining responses to audit questions and findings.
- Maintaining resource estimations for the outsourced project during the company's demand review cycle and updating the estimate because of significant milestones 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; making recommendations for refining the model.
- Monitoring and reporting on FSP performance, 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:
- You have a degree in Computer Science, Statistics, Mathematics, Life Sciences, or another relevant scientific subject.
- Extensive statistical programming experience in biopharmaceutical industry.
- A thorough understanding of clinical trial processes from data collection to analysis reporting.
- Capable of leading programmers in 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 and ADaM data sets and TFLs.
- Capable of defining and implementing an effective standardisation strategy for a product following the latest CDISC SDTM, ADaM, and defined standards.
- Regulatory submission experience preferred.
- Vendor and resource management experience preferred.
- Familiarity with other programming languages such as R or Python preferred.
- In-depth knowledge of SAS/Graph and Stat packages preferred.
- Thorough understanding of data compliance checks, such as Pinnacle 21 preferred.
- 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.
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 Heidi Hennigan at +44 2038541033 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing 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.