Senior/Principal Biostatistician, Early Phase (PK/PD)

$131,300 - $243,900/Yr

Quintiles - Durham, NC

Part-time - Mid Level

Durham, NC

Ambulatory Health Care Services

About the position

The position involves developing statistical methods sections of protocols, reviewing case report forms (CRFs), preparing analysis plans, and writing specifications for analysis files, tables, and figures. The role requires effective communication with clients and study team members regarding study execution, timelines, data quality, and interpretation of results. Additionally, the position includes interpreting analyses, writing statistical sections of study reports, and providing training and mentorship to lower-level staff.

Responsibilities

• 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, and may advise on validation checks.
• Write statistical sections of integrated reports.
• Provide expert statistical input into and review of statistical deliverables and data management deliverables.
• 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.

Requirements

• 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.
• Strong individual initiative and organizing skills.
• Strong working knowledge of SAS computing package.
• Familiarity with other relevant statistical computing packages such as nQuery.
• Strong commitment to quality and ability to effectively manage multiple tasks and projects.
• Ability to lead and co-ordinate small teams and 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).

Benefits

• Incentive plans
• Bonuses
• Health and welfare benefits