Dear Allstat
Please find the latest permanent vacancy for a Principal Statistician based in the South East.
Principal Statistician
1. Education/Qualifications Required
Graduate in any science subject together with a postgraduate qualification in Statistics or Graduate in any science subject which included a strong statistical content
2. Experience
§ 5 years or more relevant experience as a statistician within the pharmaceutical industry or clinical research organisation including the following areas:
* Study design and set up
* Study reporting and CSR production
* Phase II/III clinical trials
* SAS programming
* Working in multi-disciplinary teams
§ Comprehensive knowledge of the clinical development process and its critical paths
§ Awareness of global regulatory environment
§ Experience of a wide breadth of therapeutic areas
3. Job Summary
§ Ensures the company fulfils its obligation to provide clients with appropriate strategic and scientific advice for statistical elements of their clinical development programmes
§ Provides statistical support to studies from design to finalisation of Clinical Study Report (CSR) within agreed project timelines
§ Acts as point of contact for both internal and external customers for all statistical issues for allocated studies
§ Maintains up to date knowledge of relevant regulatory guidance and requirements
§ Provides statistical consultancy where required
§ Supports the statistical elements of Business Development
§ Provides technical leadership, training and mentoring to other team members including line management as required
4. Job Duties and Responsibilities
a) To provide statistical support during study design and set up
§ Input to and review of statistical sections of protocol
§ Sample size calculation
§ Generation of randomisation lists and blinding envelopes
§ CRF review
§ Review of data management documents and database structure to ensure data are captured appropriately for reporting
b) To write and review Statistical Analysis Plans (SAP)
§ To draft SAPs according to the company template and client requirements
§ To liaise with sponsor and internal team to ensure that proposed analyses are appropriate
§ To organise internal and sponsor reviews and approval of SAPs
§ To ensure final approval plan is filed in TMF
§ To peer review SAPs written by statistical colleagues
c) To produce data presentations for inclusion in Clinical Study Reports (CSR)
§ To perform programming of tables, figures and listings according to specifications documented in the SAP within agreed project timelines
§ To perform validation of tables, figures and listings programmed by statistical colleagues to check accuracy of results and quality of programming
d) To support the production of CSRs
§ To collaborate with the Technical Writer and Project Manager to ensure the CSR accurately documents the statistical methods used and the results of the statistical analysis
§ To review the CSR for accuracy, completeness and statistical interpretation of the results
e) To be the statistical point of contact for allocated studies
§ Attendance at study team meetings throughout the life of the study to ensure issues that may affect the statistical aspects and conduct of the study are highlighted and resolved
§ To provide solutions to issues that arise during the conduct and analysis of the study
§ To ensure sponsor and internal team members are aware of implications of relevant regulatory guidance
§ To ensure adherence to scope of work and budget
f) To support training and development of the statistics group
§ To review and update SOPs
§ To provide in-house training and mentoring for colleagues
§ To maintain and share up to date knowledge of regulatory guidance and requirements
g) To support Business Development activities
§ To Provide input to proposals and requests for information
§ To discuss and clarify statistical requirements with potential clients
§ To attend bid defence meetings as required
§ To manage statistical change orders and flag out of scope tasks to the Project Manager
5. Key Competencies
§ Exhibits sound knowledge of statistical theory and inference
§ Demonstrates excellent understanding of clinical data
§ Demonstrates good knowledge of financial management and clinical trial budgeting
§ Exhibits excellent attention to detail
§ Demonstrates excellent analytical and problem solving skills
§ Demonstrates good communications skills (written and verbal)
§ Demonstrates good motivational skills for self and others
§ Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient
§ Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments and positive interactions with customers and colleagues.
§ Demonstrates superior knowledge of relevant SOPs and processes
§ Demonstrates superior knowledge of ICH-GCP and relevant guidance
§ Identifies own training needs and initiates response
§ Exhibits superior knowledge of service culture and client interactions
§ Demonstrates the ability to prioritise and manage tasks within a flexible environment
For further information or to apply for this role send your details to Robert Whyte at James Harvard Pharmaceutical.
Email [log in to unmask] or you can call directly on +44 (0) 20 7922 7117
If this opportunity is not what you are looking for but are actively looking for a contract or permanent position as a Biostatistician or SAS Programmer then call for a confidential discussion.
Kind regards
Robert Whyte
Consultant ~ Clinical & Biometrics Division
James Harvard Pharmaceutical Ltd
T. 020 7922 7117 M. 07957 190569 F. 020 7922 7101
E: [log in to unmask]
W: www.jamesharvardpharma.com
25 - 27 Wootton Street : Waterloo : London : SE1 8TG
______________________________________________________________________
This email has been scanned by the MessageLabs Email Security System.
For more information please visit http://www.messagelabs.com/email
______________________________________________________________________
|