Sr. Biostatistician Outcome Software, Inc.
THIS JOB HAS EXPIRED Description
- Largest CRO in the world with over 27,000 employees globally.
- Ranked 6th in InformationWeek 500 Computerworld Magazine?s ?100 Best Places to Work in IT"
- Ranked 25th in the inaugural World?s Best Multinational Workplaces list from the Great Place to Work Institute.
- Outcome is the late phase and observational study division of Quintiles. We doubled in size last year
- Excellent benefits program including everything from discounts on health club memberships to up to $800 off computer, hardware/software for their home(after 2yrs of service).
- Position location can be Cambridge, MA; Rockville, MD; UK or possibly home based
- Position has been opened due to growth
- 13 person team plus two open positions
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.
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
Primary Location: USA-Massachusetts-Cambridge
Other Locations: USA-Maryland-Rockville
Organization: USA02 - US Clinical Development Svcs
||Cambridge, MA |
THIS JOB HAS EXPIRED