BullheadCityRecruiter Since 2001
the smart solution for Bullhead City jobs

Biostatistics, Subject Matter Expert

Company: PAREXEL
Location: Bullhead City
Posted on: February 21, 2021

Job Description:

The Biostatistics, Subject Matter Expert is responsible for statistical consulting, strategic advice and operational execution in drug/device /diagnostic developments up to submissions and approvals as well as successful reimbursement applications. The Biostatistics SME serves as an executive sponsor for enterprise and biotech accounts promoting client engagement.

  • Leads and contributes to strategic initiatives and working groups within GDO and Biostatistics and Statistical Programming to build a world-class group of Biostatistics experts.
  • Responsible to actively promote new business by participating in project bids and client presentations as appropriate. The Biostatistics SME works closely with Business Development and Solutions Consultants to promote Biostatistics engagement to drive new business. The Biostatistics SME is an experienced leader responsible for liaising with senior levels of management within the organization and to deputize for the Vice President or Corporate Vice President as needed.

    QualificationsSkills:
    • Excellent organizational, communication, negotiation, problem-solving, analytical and consulting skills
    • Technical leadership and contribute to a high performing team
    • Expertise in optimizing trial design, development programs, submission strategies and regulatory interactions
    • Outstanding understanding of the drug, device or diagnostic development process
    • Expertise in broad different therapeutic areas and indications
    • Thorough understanding of various statistical models and applications
    • Excellent understanding of statistical issues in clinical trials and strategies to avoid them
    • Thorough understanding of regulatory guidance and practices pertaining to specific indications and to submissions and approval processes
    • Thorough understanding of e-submissions, eCTD, etc
    • Thorough understanding of ICH guidelines
    • Excellent knowledge of all statistical and reporting processes within the Biostatistics department.
    • Strategic awareness of our business environment
    • Knowledge of the International pharmaceutical market and the services required by sales, marketing and operational support to achieve product success
      • An ability to assess situations and make and carry through difficult decisionsAdvanced ability to successfully manage a full workload across multiple projects
      • Excellent interpersonal, verbal and written communication skills (including experience in making presentations at conferences, meetings, training sessions)
      • Demonstrable experience of stakeholder/relationship management with a client focused approach to work. Able to understand the business implications of decisions and impact on customer
      • Advanced ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detailAdvanced ability to work in a matrix environment and to value the importance of teamworkComprehensive knowledge of relevant software: Windows, Word, Excel, OutlookKnowledge and Experience:
        • 15 + years of experience in the pharmaceutical industry, with broad clinical development and therapeutic area knowledge
        • Direct experience in consulting
        • Proven record and experience with development, execution and implementation of research strategies in the pharmaceutical industry
        • Experience in designing and executing drug, device or diagnostic development programs
        • Demonstration of successful direct interactions with relevant regulatory agencies like FDA/EMEA/PMDA or other local agencies
        • Experience with regulatory submissions and negotiations during the regulatory review process, including Advisory Committee preparation and participation
        • Experience with conference presentation and manuscript writing
          Education:
          • PhD in Statistics or related discipline, MS in Statistics or related discipline EEO DisclaimerParexel is an equal opportunity employer.- Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Keywords: PAREXEL, Bullhead City , Biostatistics, Subject Matter Expert, Other , Bullhead City, Arizona

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Theatre Team Member
Description: Cinemark Theatres - Century 16 South Point and XD Cashier / Crew Member /
Company: Cinemark Theatres
Location: Las Vegas
Posted on: 03/5/2021

COORDINATOR- Volunteers (PT Varied) Centennial Hills
Description: ResponsibilitiesCENTENNIAL HILLS HOSPITAL MEDICAL CENTER is a 336-bed hospital in Northwest Las Vegas that opened in January 2008. The hospital offers a wide range of medical services and procedures, (more...)
Company: Universal Health Services
Location: Las Vegas
Posted on: 03/5/2021

Team Member: Service Champion
Description: JOB TITLE: Team Member TM SUPERVISOR: Shift Manager, SM , Assistant General Manager AGM , General Manager GM , Area Coach AC BASIC PURPOSE:A Team Member is someone who enjoys people and is excited (more...)
Company: Taco Bell
Location: Las Vegas
Posted on: 03/5/2021


Escrow Assistant
Description: Company Summary First American Title Insurance Company, the largest subsidiary of First American Financial Corporation NYSE: FAF , traces its history to 1889. One of the largest title insurers in the (more...)
Company: 95-2566122 First American Title Insurance Co
Location: Las Vegas
Posted on: 03/5/2021

Emergency Room Holding Nurse (Non-Critical)
Description: Description SHIFT: Mixed rotating weekends br SCHEDULE: Full-time br br br br MountainView Hospital serves Greater Northwest Las Vegas and Southern Nevada with comprehensive medical care. (more...)
Company: MountainView Hospital
Location: Las Vegas
Posted on: 03/5/2021

Food Delivery Team Member
Description: Description Buckle up, hit the open road and start making hungry people happy as a delivery driver for Pizza Hut. That's right, we'll pay you to cruise around in your mobile office your car listening (more...)
Company: Pizza Hut
Location: Las Vegas
Posted on: 03/5/2021

Head of Fulfillment Operations
Description: Doorstead DRE 02089344 is pioneering a new class of risk-free property management i.e. iRenting that allows landlords to get a rental offer within hours. This upfront guarantee regardless of occupancy (more...)
Company: Doorstead
Location: Las Vegas
Posted on: 03/5/2021

Investment Advisor
Description: Wealthgate Trust Company LLC Wealthgate is an innovative, fast growing and well-funded boutique multi-family trust company serving a select group of ultra-high net worth families. Our clients are--entrepreneurs (more...)
Company: Wealthgate Trust
Location: Las Vegas
Posted on: 03/5/2021

Certified Medication Aide CMA
Description: Job Description Overview Now Hiring Healthcare Heroes Join our amazing team and workwithpurpose
Company: Avamere
Location: Las Vegas
Posted on: 03/5/2021

Patient Administration Specialist (68G)
Description: It takes a highly organized and efficient professional to manage day-to-day operations in military medical facilities. As a Patient Administration Specialist for the Army National Guard, you will supervise (more...)
Company: Army National Guard
Location: Las Vegas
Posted on: 03/5/2021

Log In or Create An Account

Get the latest Arizona jobs by following @recnetAZ on Twitter!

Bullhead City RSS job feeds