MurfreesboroRecruiter Since 2001
the smart solution for Murfreesboro jobs

Biostatistics Director

Company: PAREXEL
Location: Lynnville
Posted on: February 22, 2021

Job Description:

The Director 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 Director contributes to and leads strategic initiatives in the Biostatistics department and to build a world-class group of Biostatistics experts. The person will be recognized internally and externally as a statistical expert. Depending on experience, we may consider candidates at the Senior Principal Biostatistician level.
- Outstanding analytical skills
- Excellent organizational, communication, 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
- Expertize 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 also 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
- Detailed awareness of the activities of other groups within PAREXEL
- Able to work with senior managers on strategic initiatives
- Highly professional attitude
- Attention to detail
- Able to work under pressure and to motivate others

Knowledge and Experience:
- Significant experience in the pharmaceutical industry, with broad clinical development and therapeutic area knowledge
- Direct experience in consulting
- Immunology experience strongly preferred
- 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

- Ph.D. in Biostatistics, or MSc in Biostatistics with longer working experience
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, Murfreesboro , Biostatistics Director, Executive , Lynnville, Tennessee

Click here to apply!

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

I'm looking for
in category

Other Executive Jobs

Director of Provider Engagement
Description: Objective: The Director of Provider Engagement develops positive, long-term relationships with physicians, healthcare providers and healthcare systems in order to support and improve financial and quality (more...)
Company: ExecuNet
Location: Nashville
Posted on: 02/28/2021

Interim Chief Nursing Officer
Description: LifePoint Health- Health Support CenterJob Summary:The Interim Chief Nursing Officer reports directly to the CEO with a dotted line to the SVP Clinical Operations. This position will be the primary resource (more...)
Company: Health Support Center
Location: Brentwood
Posted on: 02/28/2021

Assistant Real Estate Manager
Description: he--Assistant Real Estate Manager--is responsible for supporting the Real Estate Manager in managing all aspects of a small portfolio of commercial office or industrial properties. This role will focus (more...)
Company: Foundry Commercial
Location: Nashville
Posted on: 02/28/2021

Restaurant Shift Manager - Urgent Hiring!
Description: Job DescriptionSHIFT MANAGER In a world full of quick service options, Arby's is seeking to be different and better. We want to be different for our customers and different for our employees. When you (more...)
Company: arbys
Location: Madison
Posted on: 02/28/2021

Assistant Manager
Description: If your goal is to begin a fantastic career working up to 40 hours per week where your talents will be valued and respected Murphy USA is an outstanding employer of choice. When you choose a career in (more...)
Company: Murphy USA
Location: Nashville
Posted on: 02/28/2021

Director of Compliance Audit - Registered Nurse license required
Description: Current Compassus Colleagues: Please apply via Workday.POSITION SUMMARY:The Director of Compliance Audit is responsible for modeling the 3 Company values of Compassion, Integrity, and Excellence, and (more...)
Company: Compassus
Location: Brentwood
Posted on: 02/28/2021

Program Manager (Remote)
Description: Are you looking to make a career change to a stable company This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance, vision (more...)
Company: Ajulia Executive Search
Location: Nashville
Posted on: 02/28/2021

Test Manager with Retail Domain Exp
Description: Title : Program Test Manager with Retail Domain Exp Location : Nashville TN Duration : Long term/Fulltime Mandatory Skill / Experience Lead projects of level 3 and 4 complexity as the primary delivery (more...)
Company: Cigniti Technologies Inc
Location: Nashville
Posted on: 02/28/2021

Associate Vice President, Finance
Description: Job Description - Associate Vice President, Finance 2101441 Job Description Associate Vice President, Finance - 2101441 Job : Executive Primary Location Organization : FinPlanning-Budget Analysis (more...)
Company: CTI Education Group
Location: Nashville
Posted on: 02/28/2021

Director of Operations
Description: Location: Nissan Stadium - Nashville, TN - Home of the Tennessee TitansAs the Director of Operations for Levy, you'll lead the operation and people responsible for all of the food and beverage venues/offerings (more...)
Company: Levy
Location: Nashville
Posted on: 02/28/2021

Log In or Create An Account

Get the latest Tennessee jobs by following @recnetTN on Twitter!

Murfreesboro RSS job feeds