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

Principal Biostatistician (f/m)

Company: SynteractHCR Deutschland GmbH
Location: United Kingdom United Kingdom
Reference: 27337-DR
Closing Date: 15 Aug 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Senior / Principal Biostatistician (f/m) - UK / Ely   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...

Requirements:

Senior / Principal Biostatistician (f/m) - UK / Ely   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.   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.
  • 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.
  Qualifications
  • 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
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 Antonia.Schultze@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. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.     

Apply for this job: 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

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.