IQVIA Sr. Biostatistician, RWES: Home or Office-based in Kansas City, Missouri
Real-world data is changing the industry standard approach for real-world research study design and execution and opening-up innovative real-world research design and analysis options. As a Senior Biostatistician, with a strong understanding of issues related to analyzing real world data, you will be working with a talented team developing and applying innovative methodology to solve complex analytical problems from multiple data platforms.
Your role will include development of statistical methods sections of protocols and review case report forms (when applicable). Prepare analysis plans and write specifications for analysis files, tables, and figures.
As part of your responsibilities you will:
• Perform protocol development support, sample size calculation, protocol and CRF review and also advise data management staff on database design, and critical data. May advise on validation checks.
• 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.
• Manage customer relationships and provide training and mentorship to junior staff members and newcomers.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Excellent written and oral presentation 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 Real World Studies
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)
Take strong individual initiative, show dedication to quality and present excellent organization skills
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.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
USA-North Carolina-Durham, USA-Missouri-Kansas City, USA-Pennsylvania-Philadelphia, USA-New York-New York City, USA-Maryland-Rockville