Senior Boistatistician

Key People

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Job ID :

9280


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Master of Science


Address 1 :

United Kingdom,--St.Albans,St. Albans,


Key Skills :

SAS, R, CDISK, ICH/GCP, SPEAK ENGLISH, INNOVATIVE


Salary :

£50000 - £55000 per annum


Date Posted :

30 Oct, 2017



Company Name :

Key People


Location1 :

St. Albans




Job Category :

Biostatistics Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

100.00%





Description

Author the Statistical Sections of Protocol.

Propose and Review the Study design.

Calculate the sample size.

Review the Case Report Form (CRF).

Review the Edit Check Document (specifically for critical modules like RECIST 1.1 etc.).

Write the randomization specifications and coordinate and finalize all the randomization activities with the IWRS vendor.

Author Statistical Analysis Plan (interim and final as appropriate).

Perform the Statistical Analysis (Efficacy and Safety (key safety like Adverse Events)) using SAS.

Ensure quality of all the outputs developed.

Perform the role of validator as appropriate.

Provide Statistical Consultancy on an ongoing basis for projects.

Perform Futility and Efficacy analysis as appropriate for interim analysis and interact with third party independent Statistician.

Defend the Statistical Analysis at the IDMC meetings as appropriate.

Write the specifications for the efficacy analysis. Review the Specifications for the Safety Analysis.

Organize Data Review Meetings (equivalent to Blinded Data Review (BDR) or Dry Run) and lead all the statistical discussions.

Work Collaboratively with the data management, Clinical Operations, Medical Writing and the Pharmacovigilance team as appropriate.

Provide inputs to the regulatory affairs for all the discussions with the health authorities (e.g. ANSM, EMA, FDA).

Review the Clinical Study Report and provide statistical inputs as appropriate.

Perform exploratory analysis as appropriate.


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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