PlanoRecruiter Since 2001
the smart solution for Plano jobs

Biostatistics, Subject Matter Expert, Associate Director/Director

Company: PAREXEL
Location: Plano
Posted on: September 16, 2020

Job Description:

Job DescriptionThe 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 decisions * Advanced 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 detail * Advanced ability to work in a matrix environment and to value the importance of teamwork * Comprehensive knowledge of relevant software: Windows, Word, Excel, Outlook Knowledge and Experience : * 10-12 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.SDL2017

Keywords: PAREXEL, Plano , Biostatistics, Subject Matter Expert, Associate Director/Director, Executive , Plano, Texas

Click here to apply!

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

I'm looking for
in category

Other Executive Jobs

General Manager
Description: Apply on Company Website General Manager Sonic Drive-In Quinlan, TX Posted 1 hour ago Apply on Company Website The Job: nnAs a McCans Sonic Group General Manager, you are responsible for overseeing and (more...)
Company: Sonic Drive-In
Location: Quinlan
Posted on: 09/22/2020

Associate Manager Nursing - General Surgery - Fulltime
Description: Interested in a career with both meaning and growth Whether your abilities are in direct patient care or one of the many other areas of healthcare administration and support, everyone at Parkland works (more...)
Company: Parkland
Location: Dallas
Posted on: 09/22/2020

Customer Success Manager
Description: THE TEAMAqua's Customer Success team solves real-world security challenges for our customers. We are the only cloud native security provider securing the build, infrastructure, and running workloads of (more...)
Company: Aqua Security
Location: Dallas
Posted on: 09/22/2020

Key Account Director South
Description: Title Key Account Director- South Potential Job Title: Key Account Director - South- Texas, LA, AK, MS. TN Location: Remote- Dallas, Houston, Austin, Memphis, Little Rock Indivior is a global specialty (more...)
Company: Indivior
Location: Dallas
Posted on: 09/22/2020

Assistant Restaurant Manager - 2680 W. MAIN STREET- Braum's
Description: Overview br br Assistant Restaurant Manager-Food Service Supervisor-Management br br If you are a positive, energetic person looking for a career that offers an excellent compensation package (more...)
Company: Braum
Location: Frisco
Posted on: 09/22/2020

Operations Manager Floor
Description: Req ID BR Company Summary What started small, with a single discount store and the simple idea of selling more for less, has grown over the last 50 years into the largest retailer in the world. Each week, (more...)
Company: Walmart
Location: Fort Worth
Posted on: 09/22/2020

Tax Senior Manager - Personal Wealth Advisors
Description: Job DescriptionEisnerAmper is seeking a Senior Manager to join our Tax Services/Personal Wealth Advisors group in out San Francisco office. We are seeking someone who thrives in a growing environment (more...)
Company: EisnerAmper
Location: Dallas
Posted on: 09/22/2020

Director- Healthcare & Life Sciences
Description: At West Monroe, our people are our business. We pride ourselves on bringing a different mindset to consulting---and that takes a different approach: highly collaborative, flexible, and tenacious. Our (more...)
Company: West Monroe Partners
Location: Dallas
Posted on: 09/22/2020

Vice President Global Account (Remote) - $400,000/year USD
Description: Do you want to sell the telco industry's most visionary and innovative software Are you a senior account exec or consulting partner who can get meetings with any Tier 2 telco CxOs Do you love closing (more...)
Company: Crossover for Work
Location: Dallas
Posted on: 09/22/2020

Assistant Restaurant Manager - 1100 WEST MOORE- Braum's
Description: Overview br br Assistant Restaurant Manager-Food Service Supervisor-Management br br If you are a positive, energetic person looking for a career that offers an excellent compensation package (more...)
Company: Braum
Location: Terrell
Posted on: 09/22/2020

Log In or Create An Account

Get the latest Texas jobs by following @recnetTX on Twitter!

Plano RSS job feeds