Senior Biostatistician

Location: North Sydney, New South Wales, Australia, Perth, Western Australia, Australia, Liverpool, NSW, Australia, Melbourne, Australia, Frankston VIC, Australia, Gosford NWS, Australia, Adelaide, South Australia, Australia, Newcastle NSW, Australia, Merewether NSW, Australia, Hobart, Tasmania, Australia, Mount Isa, QLD, Australia

Time Type: Full time

Job Description

Job Overview
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. Accountable for controlling costs and maximizing revenue recognition. Provide training, guidance and mentorship to lower level and new staff.

Essential Functions

Production of High‑Quality Deliverables

• Completes and reviews complex tasks with strong accuracy.
• Performs required validations per Standard Operating Procedures (SOPs), reviews statistical programming deliverables and manages Quality Control (QC) documentation.
• Provides oversight for activities related to database lock, randomization, and unblinding, ensuring procedural compliance.

Leadership

• Serves as statistical team lead for assigned studies.
• Partners with Project Team Lead to deliver on time, within quality and budget expectations.
• Builds customer relationships and leads statistical discussions.
• Runs meetings with customers, provides updates in internal project team meetings, and contributes to project finance reporting.

Data Management Support

• Advises on database design, validation checks and critical data.
• Inputs into Data Issues log and follows issues to appropriate resolution.

Statistical Analysis Plan (SAP) & Shells

• Authors or QC reviews SAPs and shells.
• Leverages internal resources for complex statistical methods.

Datasets

• Reviews analysis dataset programming specifications to ensure alignment with the SAP.
• Reviews analysis datasets to ensure proper derivations are employed and industry standards, such as Clinical Data Interchange Standards Consortium (CDISC), are followed.

Tables, Listings & Figures (TLFs)

• Reviews programming specifications and checks resulting programming output for format and content, questions specification as needed. Ensures consistency across items produced.
• Ensures programmers maximizes programming efficiency with use of internal tools, where applicable.

Timelines & Financials

• Understands 'scope of work', contract and budget assumptions.
• Plans timelines, forecasts resources, and flags out‑of‑scope work.
• Shares accountability for study financial performance, cost control and maximizing revenue recognition.

Knowledge Sharing & Mentorship

• Trains and mentors junior staff.
• Supports other team members and promotes knowledge transfer.

Risk Management

• Identifies and mitigates delivery and quality risks proactively.

Additional Responsibilities

• May lead across multiple protocols within a compound.
• Authors/QCs statistical sections of protocols, assists with sample size calculations, Case Report Form (CRF) reviews.
• May contribute to proposals, Request for Proposal (RFPs), and bid defenses.
• Reviews or drafts Clinical Statistical Report (CSRs)/statistical reports.
• May serve as unblinded lead statistician.
• Performs other duties as assigned.

Qualifications

• Minimum Bachelor’s degree in Biostatistics, Statistics or related field with 3–5 years of relevant experience in CROs or Pharmaceutical industry.
• Strong statistical, analytical, and problem‑solving skills.
• Excellent written and verbal communication.
• Excellent attention and accuracy with details.
• Detailed knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and clinical research regulations.
• Familiarity with moderately complex statistical methods applied in clinical trials.
• Strong initiative, organization, and ability to manage multiple tasks.
• Proficiency in SAS. Familiarity with other relevant statistical programming language such as R.
• Ability to lead small teams and collaborate effectively.
• Working knowledge of relevant data standards (such as CDISC/Analysis Data Model (ADaM)).

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.