Biostatistician / Statistical Programmer

Job Overview

Design study specific Common Data Models and eCRFs. Manage and harmonize raw data. Prepare quality checks and analysis plans and write detailed specifications for quality checking of raw and harmonized data, analysis files, tables, listings and figures. Provide training, guidance and mentorship to lower level and new staff.

Essential Functions

Production of High-Quality Deliverables

Completes and reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken. Checks programming logs for cleanliness and correct processing of data. Inputs into Data Issues log and follows issues to appropriate resolution.

Leadership

Perform data management lead role on single studies. Through this, works closely with the Project Team Lead and supervisor to deliver on time, with high quality and within budget. Build and maintain effective customer relationships, driving data quality discussions, providing support and/or guidance for data enhancement activities. Demonstrates and promotes efficient communication. If in lead role, runs meetings, documenting where necessary and following up on actions. Actively participates in internal project team meetings, provides timely progress updates.

Data Management

Assist in reviewing or advising data management staff on database design, validation checks and critical data. Handles data issue resolutions. If in lead biostatistical role, handles lock and unblinding process with appropriate supervision.

Statistical Analysis Plan (SAP) and Shells

Performs quality control review (QC) of SAPs and shells. Make best use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). May author or QC complex SAPs, under supervision if needed.

Datasets

Writes and maintains programming specifications. Programs assigned datasets to internal or industry standards. Handles dataset derivations and assignment.

Tables, Listings and Figures (TLFs)

Writes programming specifications for statistical analyses outputs. Programs TLFs, maximizes programming efficiency with use of tools, where applicable. Checks resulting output for format and content, and questions specification as needed. Ensures consistency across items produced.

Timelines

Plans and documents timelines, forecasts resource needs, suggests work may be out of scope.

Knowledge Sharing

Helps train staff regarding operational items. Mentors junior staff. Supports colleagues and provides motivation as needed.

Risk Management

Identifies risks to project delivery and/or quality and spends time to proactively avoid as well as proposes solutions to mitigate risks. Where possible, anticipate risks to minimize need for study level escalations.

Study Start up

Assist with protocol development, sample size calculation, protocol and case report form (CRF) review.

Protocol

Performs quality control (QC) review of the statistical section of a protocol (making best possible use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods).

Clinical Study Report (CSR)

Reviews CSR or statistical report.

Customer

On occasion, may serve as primary point of contact for customer. May also consult on operational topics with clients.

Lock and Unblinding Process

Handles the database lock and unblinding process. May participate on the biostatistics randomization team (drafts randomization specifications and/or reduce or perform quality control (QC) review of randomization schedules). May serve as unblinded lead statistician.

Qualifications

• Bachelor's Degree Biostatistics or related field and 1 - 3 years relevant experience Req Or
• Master's Degree Biostatistics or related field and 1-3 years relevant experience Req Or
• Ph.D. Biostatistics or related field Req
• Typically requires 1-3 years of prior relevant experience, or equivalent combination of education, training and experience.
• Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
• 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.
• Strong organizing skills.
• Strong working knowledge of R computing package.
• Familiarity with other relevant statistical computing packages such as SAS optional.
• Strong commitment to quality.
• Ability to effectively manage multiple tasks and projects.
• Ability to provide and accept direction of lead team members.
• Ability to solve moderately complex problems.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.