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Job Details

Director, Biostatistics

Company: SynteractHCR Deutschland GmbH
Location: United States Anywhere, US None
Reference: 27638
Closing Date: 21 Aug 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Director, Biostatistics - Anywhere, US Home-based or Office-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:

Director, Biostatistics - Anywhere, US Home-based or Office-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 Director Biostatistics manages the overall activities of line managers and Biostatisticians, responsible for performing the data analysis 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. Also responsible for cross functional standardization and harmony, technology and process improvement and resource forecasting.   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.
  • Assigns and manages resource to meet overall and critical project deliveries.
  • 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.
  • Bibliography research for statistical analysis techniques
  • Provides statistical guidance for other company Biostatisticians.
  • Management responsibilities require one to assist with hiring and assimilating employees; to provide on-going feedback and development; to document and deliver annual performance reviews; to coach, counsel and make determination of involuntary separation of employees as appropriate.
  • Facilitates the communication between the SAS programmer(s), project team, Sponsor and vendors.
  • Participate in management meetings to analyze/discuss department motivation improvement, training, resourcing, budgeting, personnel issues, process improvement.
  • Prepare group budget yearly to present to management.
  • Reports the status and progress of the team’s projects to management on an on-going basis.
  • Director responsibilities include participating in corporate-wise process improvement including but not limited to technology vendor selection, marketing, technical capabilities, employee morale.
  • Manages the human resources for the department, including resource projects and assignment of projects.
  • Manages cross functional issues by facilitating consistency and identifying area of standardization and to anticipate problems and identify solutions to meet corporate objectives.
  • Provides input into project timelines and ensures that adequate resources are utilized to meet timelines.
  • Provides guidance into development and implementation of data management and programming standards and ensures that the standards are followed.
  • Provides input into the development of data management and programming training and continued education.
  • Ensure the programming group delivers quality output to clients and achieves agreed upon revenue margins.
  • Oversee the coordination of programming operations and project deliverables
  • Be responsible for the continued growth, development and management of the department to ensure their performance meets/exceeds both the business and their own personal goals/objectives.
  • Ensure resources are managed effectively, including reviewing the productivity and utilization of the group.
  • Lead and support the continuous improvement and implementation of processes and technologies within the programming group.
  • Provide technical expertise and solutions to solve problems and improve efficiency across functions, projects and customers.
  • Exhibit credibility and expertise in Business Development activities with existing and potential new clients.
  • Provide operational input into proposals including participation in client presentations
  • Provide accurate forecasting figures for the annual budget and manage Profit & Loss (P&L) throughout the year to ensure that the budgetary goals are met or exceeded.
Qualifications
  • Master's degree or equivalent in statistics, mathematics or related field of project and a minimum of 10 years related experience or equivalent combination of education and 5+ years’ experience effectively managing results in terms of costs and/or methods and employees and a minimum 1-2 years effectively contributing to the business plan at both the tactical and strategic levels.
  • Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
  • Advanced proficiency in BASE SAS, or other statistical software.
  • Advanced understanding of the development, programming, management, validation and documentation maintenance of all programming tasks
  • 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.
  • Excellent 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!    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.   

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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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