Connecting...

Biostats Manager x 2

Location: London, England Salary:
Sector: Regulatory Affairs Type: Permanent

Real Staffing have exclusively partnered with one of the world's largest independent biotechnology companies.

Due to an increase in work demand, our client is currently in need of a Biostatistics Manager

To manage all statistical aspects pertaining to clinical activities meet required standards and are statistically correctly. The Biostatistics Manager will influence study design, defending statistical approaches both internally and externally ensuring strict adherence to all Policies, SOPs and other controlled documents. and co-ordinate all activities related to statistical planning, programming, analysis and reporting in support of R&D projects, particularly of clinical studies and programs.

The ideal post-holder will need:

  • Providing statistical contributions, statistical review and quality control of Key Design Elements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications
  • Being familiar with statistical policy and strategy
  • Staying abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field
  • Communicating the role of the Global Biostatistics department, and may contribute to statistical training within Global Biostatistics and within Amgen
  • Assisting in the review of Policies, SOPs and other controlled documents
  • Assisting with study and systems audits conducted by CQA and external bodies

Requirements:

  • Designing, analysing and reporting clinical trials
  • Lifecycle drug development experience including pre-clinical, clinical development and post marketing
  • Authored a protocol, DRT/DCM, SAP or CSR
  • Project planning experience
  • Excellent communication skills

If you're interested please get in touch with an up to date CV! If you know anybody else who might be interested I'm happy for you to forward on my details.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales