Job Description:
* Our Client is a top tier Pharmaceutical organisation looking for an experienced Statistical Manager to
support the Biostatistics team by carrying out and overseeing the programming activities of statistical
programmers and external vendors.
* As a senior member of the team you will contribute to the overall efficiency and best
practice running of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment.
* 12 month contract with competitive daily rate on offer.
Role:
* Overseeing and managing programming activities conducted by external vendors (e.g., CROs), supervising Programmers (e.g., Statistical Programmers) and their activities including assignment of projects.
* Working with external vendors in order to develop or monitor the content and structure of SAS data sets and working closely with project Statisticians to ensure related timelines are met for producing analysis data sets, tables, listings and graphs for clinical study reports, maintaining standards for programming activities.
* Providing statistical programming and validation support for clinical study reports.
* Developing and maintaining SOPs, SWPs and other related technical documents, providing input to the Database and CRF Development and providing feedback to the Data Management.
* Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents and determining and researching SAS software upgrades and related system maintenance issues.
* Pursuing individual professional development and continuing education opportunities, attending conferences and bringing in new ideas to improve the programming process.
Experience and Qualifications:
* Bachelor's degree in Statistics, Computer Science, Mathematics, or a related science discipline preferred.
* Experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment.
* Some project experience in a pharmaceutical/CRO programming environment or demonstrated significant leadership of SAS programming activities in a clinical pharmaceutical/CRO environment.
* Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office.
* Proven experience with Unix and Windows operating systems.
* Understanding of the software development life cycle.
* Understanding of FDA guidelines.
* Good organisation, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality.
* Applies good judgment and demonstrates initiative to resolve issues.
* Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment, managing that team as required.
Contact:
* Christian Simon - Talent Acquisition Specialist
* Tel: 020 8560 2300 for a confidential discussion
* Or send your CV quoting job ref AS4905 to [log in to unmask]
* AXESS Limited, Parkshot House, 5 Kew Road, Richmond, Surrey, TW9 2PR
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