Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Senior Biostatistician

Company: Synteract
Location: Germany Anywhere, EU EU
Reference: 27611-EG
Closing Date: 16 Jan 19
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Senior Biostatistician - Anywhere, EU Office-based or Remote-based   Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro...

Requirements:

Senior Biostatistician - Anywhere, EU Office-based or Remote-based   Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.   Position Overview The senior Biostatistician performs the data analysis with supervision for assigned clinical studies.  Works closely with the clinical team, project Sponsor, data manager, other statisticians and programmers to analyze and present the data based on Sponsor specifications.  He/she develops, creates, verifies/validates and maintains the programs for assigned projects in compliance with standard operating procedures.   Specific tasks would include:

  • 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.
  • Serves as lead statistician for assigned projects, coordinates and monitors work assignment of other supporting Biostatisticians and programmers.
  • Creates/maintains analyses, tables/listings/figures
  • 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.
  • Assists in writing and/or reviewing Statistical Reports.
  • 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.
  • Represents Biostatistics in communication with Sponsors.
  • Bibliography research for statistical analysis techniques
  • Provides statistical guidance for other company Biostatisticians.
  • Leads specialized Biostatistics development projects as requested by Management.  
Qualifications
  • Master's degree or equivalent in statistics, mathematics or related field of project and a minimum of 5 years related experience or equivalent combination of education and experience
  • Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
  • Intermediate 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.
  • Nonverbal symbolism experience (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases.
  • Good proficiency in Microsoft Word, Excel, and PowerPoint, Access.
  • Effective verbal and writing skills; English + local language, if relevant.
If you’re passionate about bringing clinical trials to life, we encourage you to apply today!  Please apply online stating your earliest start date/notice period and your desired salary. If you have any questions regarding your application please contact Livia.Anstey@synteract.com   Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Candidates must possess current and valid authorization to work in the country to which they are applying.  

Apply for this job: Senior Biostatistician

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

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.