YoungstownRecruiter Since 2001
the smart solution for Youngstown jobs

Biostatistics Director

Company: PAREXEL
Location: Youngstown
Posted on: February 23, 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.
QualificationsSkills:
- 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

Education:
- 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, Youngstown , Biostatistics Director, Executive , Youngstown, Ohio

Click here to apply!

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

I'm looking for
in category
within


Other Executive Jobs


Assistant Salon Manager - Southland Shopping Center
Description: Assistant Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to support other stylists Then let s talk Maybe you re a stylist who wants more
Company: Great Clips
Location: Macedonia
Posted on: 02/28/2021

General Manager - Store 4406, Tallmadge, OH
Description: General Manager - Store 4406, Tallmadge, OH in Tallmadge, OH at Advance Auto Parts At Advance Auto Parts we have a passion for YES. Each day we are motivated by a passion to help our Customers. We have (more...)
Company: Advance Auto Parts
Location: Tallmadge
Posted on: 02/28/2021

Molding Manager
Description: As the Molding Manager you would put programs and processes in place to ensure safety, reliability, efficiency and regulatory compliance for a manufacturer of injection and blow molded components. Duties/Responsibilities (more...)
Company: Nesco Resource
Location: Wooster
Posted on: 02/28/2021


Group Account Director
Description: Group Account Director in Cleveland, Ohio - Careers at Healthcare Consultancy Group Group Account Director in Cleveland, Ohio - Careers at Healthcare Consultancy Group Please Enable Cookies to Continue (more...)
Company: Regional Recreation Corporation of Wood Buffalo
Location: Cleveland
Posted on: 02/28/2021

Infrastructure Project Manager
Description: RESPONSIBILITIES:Kforce has a client that is seeking an Infrastructure Project Manager in Cleveland, OH. Responsibilities: ul li Infrastructure experience working with small Data centers li Assist (more...)
Company: Kforce Technology
Location: Cleveland
Posted on: 02/28/2021

Molding Manager
Description: As the Molding Manager you would put programs and processes in place to ensure safety, reliability, efficiency and regulatory compliance for a manufacturer of injection and blow molded components. Duties/Responsibilities (more...)
Company: Nesco Resource
Location: Wooster
Posted on: 02/28/2021

Branch Manager
Description: Crown Services is currently hiring a Branch Manager for our Cleveland location With over 50 years in the staffing industry, we here at Crown Services pride ourselves on matching talent to opportunity (more...)
Company: Crown Services, Inc.
Location: Cleveland
Posted on: 02/28/2021

Program Manager
Description: Program Manager Under the direction of the WTI ManagedAssets Team Manager this position provides day-to-day support to sales representatives and their clients focused on large local, regional or national (more...)
Company: Tremco
Location: Cleveland
Posted on: 02/28/2021

Director of Gift and Estate Planning
Description: Cleveland State University br Engaged Learning To approach the unknown with curiosity-to explore. To face challenges with courage-to find solutions. This is a Viking. A Viking values wisdom. Wisdom (more...)
Company: Cleveland State University
Location: Cleveland
Posted on: 02/28/2021

Branch Manager, Galleria
Description: Job Description br br We are looking for enthusiastic, motivated individuals to lead all aspects of branch banking. As a Branch Manager, you will complete a six month training program. While maintaining (more...)
Company: Dollar Bank
Location: Cleveland
Posted on: 02/28/2021

Log In or Create An Account

Get the latest Ohio jobs by following @recnetOH on Twitter!

Youngstown RSS job feeds