At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services.
As one of FORTUNE’s ‘Most Admired Companies’ in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health.
Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports. Provide training, guidance and mentorship to lower level and new staff.
Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis.
Perform protocol development, sample size calculation, protocol and CRF review.
Advise data management staff on database design, and critical data. May advise on validation checks.
Write statistical sections of integrated reports.
Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data).
Act as statistical team lead for single complex studies or groups of studies.
Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. May manage project budget and resource requirements.
Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings.
Manage customer relationships.
Provide training and guidance to lower level and new staff.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Excellent written and oral communication skills including grammatical/technical writing skills
Excellent attention and accuracy with details
In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials
Familiarity with moderately complex statistical methods that apply to applicable clinical trials
Strong individual initiative
Strong organizing skills
Strong working knowledge of SAS computing package
Familiarity with other relevant statistical computing packages such as nQuery
Strong commitment to quality
Ability to effectively manage multiple tasks and projects
Ability to lead and co-ordinate small teams
Ability to solve moderately complex problems
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Working knowledge of relevant Data Standards (such as CDISC/ADaM)
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
PhD in biostatistics or related field and 1 year relevant experience; Master's degree in biostatistics or related field and 3 years relevant experience; Bachelor's degree in biostatistics or related field and 5 years relevant experience; or equivalent combination of education, training and experience
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Did You Know?
* Quintiles helped develop or commercialize 98 of the Top 100 best-selling products of 2015
* Quintiles has 36,000 employees conducting business in more than 100 countries
* Quintiles was named to FORTUNE’s World’s Most Admired Companies® 2016 list
* Quintiles was named as a 2016 World’s Most Ethical Company® by the Ethisphere Institute
Primary Location: GBR-ENG-Reading
Other Locations: FRA-Alsace-Strasbourg, PRT-Lisbon-Lisbon, ITA-Lombardia-Milano, ESP-Madrid-Madrid, IRL-Leinster-Dublin
Organization: GBR02 - UK Product Development