People Places Events In History Terms Organizations
Home Invites Members Groups Events Careers Videos News Photos Blogs Polls Forums Chat
Home > Career Center > Job Seekers > Job Search
Job Title: Strategic Biostatistics Director
Company Name: Quintiles
Location: Research Triangle Park, NC
Position Type: Full Time
Post Date: 05/29/2017
Expire Date: 06/28/2017
Job Categories: Publishing, Research & Development
Job Description
Strategic Biostatistics Director

Provide
strategic biostatistical input to internal and external clients in drug,
biologic, or device development areas with an emphasis on clinical trial
design, interim decision making, and analysis using novel and advanced
statistical methods.

 

RESPONSIBILITIES

 

      Provide
strategic biostatistical input at the study level to internal and external
clients which ensure the optimal clinical trial design will be implemented.

      Support the
development of efficient CDPs for external clients by incorporating innovative
statistical methods to meet the goals and objectives of their development  program

      Represent clients
at meetings with FDA or European regulatory authorities to defend protocol
designs or analyses.

      Contribute
to the biostatistical component of Due Diligence (DD) assessments of compounds
for small or moderate value opportunities for which investment is being
considered, and provide strategic biostatistical support on individual studies
in cases where investment has already been made.

      Maintain
knowledge and awareness of developments in biostatistics, clinical trial
methodology, and regulatory requirements that impact on design or analyses for
multiple therapeutic areas. May carry out new developments in areas of
statistical design or analysis that can be benefited by clients and used to
give Quintiles a greater edge over competing CROs.

      Market
Quintiles strategic biostatistical expertise, may include:(i) publishing papers
that demonstrate strategic bios expertise in key areas (such as adaptive design,
multiple comparisons, Bayesian analysis, etc.); (ii) giving presentations at
conferences, particularly those attended by key decision makers for outsourcing
high value business; (iii) and publicizing internally to key groups.



      Participate
in the provision of training to internal and external clients on advanced
statistical topics or advanced case studies.

Qualifications & Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

 

      Good
knowledge of innovative and complex statistical analysis methods that apply to
clinical trials, which can be used to cut time, cut costs, and/or increase
chance of success;

      Good
knowledge of the new and cutting-edge design approaches (including some types
of adaptive designs) that can beneficially be applied to clinical trials;

      Ability to
develop new statistical methods and strategies;

      Good
knowledge of current FDA or EMEA regulatory requirements with respect to study
designs, primary endpoints, and acceptable analyses for two or more therapeutic
areas;

      Good
understanding of the complete clinical drug development process;

      High level
knowledge of SAS and R;

      Excellent
written and oral communication skills

      Ability to
establish and maintain effective working relationships with coworkers, managers
and clients

 

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

 



























      PhD or
educational equivalent in biostatistics or related field and 10 years relevant
experience; or Master’s degree or educational equivalent in biostatistics or
related field and 15 years relevant experience; or equivalent combination of education,
training and experience.

Share |
Contact Information
Company Name: Quintiles
Website:https://quintiles.taleo.net/careersection/scrapingusquintiles/jobdetail.ftl?job=1610738&lang=en&src=JB-19340
Apply Now | Forward Job to a Friend | More Jobs From This Employer
Employer Showcase
>> more | add
Latest Jobs
Project Coordinator (Temporary) - Facilities Management with Azusa Pacific University in Azusa, CA.
Resource Coordinator - Writing Center with Azusa Pacific University in Azusa, CA.
Project Coordinator - Facilities Management with Azusa Pacific University in Azusa, CA.
School of Education, Administrative Director with Azusa Pacific University in San Diego, CA.
Senior Marketing & Communications Director with Room to Read in San Francisco, CA.
>> more | add
Latest Member Activity
scratchylus sene just posted a blog entitled 'sweet child precious little child scratchylusempressreggae kiddus i live @ vinyl thursdays ja'. 11:42PM
scratchylus sene just became a new member. 11:28PM
darlene sanders just became a new member. 01:37PM
isha sharma just edited her profile. 07:02AM
tazadaq shaah just posted a blog entitled 'tazadaq & bryant's secured party creditor success story status correction done right '. 06:56AM
tazadaq shaah just posted a blog entitled 'tazadaq , why doesn't my accepted for value work, is it a scam '. 07:07AM
tazadaq shaah just posted a blog entitled 'i never consent to owing anything on the public side i discharge all public debts va public law 7310 '. 07:23PM
gregory boulware, esq. just posted a blog entitled '~ "by the bootstraps" ~'. 09:51AM
tazadaq shaah just posted a blog entitled 'new york city housing and why you must learn contract law = contract = law always argue the contract '. 08:30AM
tazadaq shaah just posted a blog entitled 'leanring to operate as a secured party creditor traffic infrations and child issues in the system '. 11:17AM
tazadaq shaah just posted a blog entitled 'realestate, nursing home, government benefits & secured party creditor '. 07:53AM
ebonie scott just became a new member. 05:13PM
>> more | invite friends