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Job Details

Senior / Principal Biostatistician (f/m)

Company: SynteractHCR Deutschland GmbH
Location: Ely, United Kingdom
Reference: 27337
Closing Date: 14 Jan 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Senior / Principal Biostatistician (f/m) UK / Ely   Synteract is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development, located in EU, RUS, US and South America. As we are growing we are looking for a dedicated Senior / Principal Biostatistician to join our Biometrics Team in Ely.

Requirements:

Senior / Principal Biostatistician (f/m)

UK / Ely

 

Synteract is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development, located in EU, RUS, US and South America. As we are growing we are looking for a dedicated Senior / Principal Biostatistician to join our Biometrics Team in Ely. We offer you a challenging and rewarding job opportunity in a fast moving, international and flexible environment and a highly motivated team.

 

Tasks and Responsibilities

  • Maintains the full-scope of responsibility for assigned projects: ensures on-time delivery, communicates the status of projects to internal teams and project Sponsors, executes quality assurance procedures on work produced by others and ensures statistical analysis is being done according to specifications.
  • Provides input into the strategic direction and growth of the department.
  • Identifies opportunities for improvement and leads efforts to effect the required change.
  • Acts as a liaison between biostatistics and other departments including data management, medical writing, sales, and project management.
  • Serves as lead statistician for assigned projects, coordinates and monitors work assignment of other supporting Biostatisticians and programmers.
  • Writes/Reviews Statistical Analysis Plan (including Mock tables/listings).
  • Reviews Case Report Forms for assigned projects to ensure data is collected appropriately to achieve the analysis defined in the protocol.
  • Ensures table, listing and statistical analysis programming is being done according to Sponsor specifications (where not defined, within company standards).
  • Creates/QC specifications for, and programs, derived data sets.
  • Performs programming validation and ensures all Quality Control efforts have been followed.
  • Reviews protocol, providing feedback as well as adding to the methods section and providing input on project design issues, endpoint definition and sample sizes.
  • Provides sample size calculation and documentation.
  • Generates Randomization Schedules.
  • Works closely with Sponsor to ensure a high quality, timely delivery of tables/listings/figures and statistical reports.
  • Provides statistical guidance for other company Biostatisticians.
  • Leads specialized Biostatistics development projects as requested by Management
  • Assists Sponsors in developing regulatory strategies.
  • Provides Sponsors with statistical representation at regulatory meetings.

 

Your Profile

  • Master's degree or equivalent in statistics, mathematics or related field
  • 10+ years related working experience (ideally from a CRO background)
  • Working knowledge of GCPs, ICH guidelines, EMA and other applicable country regulations.
  • Advanced proficiency in BASE SAS, or other statistical software is advantageous, but not required.
  • Understands the sequence of running programs to ensure up-to-date data and to troubleshoot, debug programming problems and to identify data trends.
  • Good proficiency in Microsoft Word, Excel, and PowerPoint, Access.
  • Effective English verbal and writing skills
  •  

To apply

 

Have we sparked your interest? Then we are looking forward to receiving your application! Please apply stating your earliest start date/notice period and your desired salary. If you have any questions regarding your application please contact Antonia.schultze@synteract.com

 

 

 

 

 


Apply for this job: Senior / Principal Biostatistician (f/m)

Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

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