Hello Everybody
 
We are handling a new role that may interest you. Working with one of the leading Biopharmaceutical company in Cambridge (UK), this is a role for a Biostatistics Manager.
 
The role is as follows:
 

Purpose:
To co-ordinate the design statistical analysis and reporting of individual studies

To represent Biostatistics on study teams eg GCSTs

To provide statistical input for publications presentations and in-house decision-making

Responsible for:

Ensuring all statistical aspects of documentation pertaining to individual clinical studies meet required standards and are statistically correct

Ensuring all statistical aspects of documentation pertaining to non-registrational activities meet required standards and are statistically correct

Adhering to all Amgen Policies SOPs and other controlled documents

Key activities:

Function as a Study Statistician eg on GCSTs with the following key activities

Participate in study team meetings

Project-manage all study team activities within Biostatistics according to agreed resource and timeline plans

Create statistical text for study concept documents and protocols study design endpoints sample size methods for analysis

Review and approve randomisation specifications

Create statistical analysis plans

Create templates for tables listings and graphs

Review and approve SDF dataset specifications

Review and approve key study-related documents produced by other functions eg CRFs Data Management Plans etc

Write test validate and execute software programs to produce SDF datasets and tables listings and graphs statistical analysis outputs for inclusion within CSRs ISS ISE IBs INDs publications and other communications

Participate in the finalization of protocol deviations and analysis sets

Approve database freeze

Unblind load and check accuracy of treatment assignment data

Create flash reports or flash memos

Create statistical text for CSRs clinical publications and other communications

Plan and execute statistical review and QC of CSRs clinical publications and other communications

Assist in planning and contribute to compilation of ISSISE
 
Oversee the work of outsourcing partners and vendors at study level

Create Requests for Proposals RFPs from outsourcing vendors for statistical services

Contribute to decisions on selection of outsourcing partners

Participate in the development and review of Amgen Policies SOPs and other controlled documents

Participate in study and systems audits by Amgen CQA and external bodies and respond to audit questions and findings

Provide input to and participate in intra-departmental and global Biostatistics meetings

Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field

Promote and communicate statistical awareness and the role of the Biostatistics department internal & external scientific process

Contribute to the continuous improvement of Global Biostatistics
 
 

 
 
For more information or to apply for this role, please get in touch with me at this address or on 01438 743047.

Kind regards

Jonathan

Jonathan Hart-Smith
Managing Director

CK Clinical Limited
9 High Street
Stevenage
SG1 3BG

DD: 0845 034 3082
T: 01438 743047
M: 07985 152216
Internal: 2019
F: 01438 723800
W: www.ckclinical.co.uk

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