Senior Biostatistician

IQVIA; India; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

IQVIA is seeking an experienced biostatistician with 7+ years in Medical Affairs and Real-World Evidence. The role requires oncology/haematology expertise, SAS and/or R proficiency, and strong CDISC ADaM/SDTM knowledge. The candidate should lead QC of outputs and contribute to cross-functional teams across PAN India.

Experience with AI-driven methodologies is a plus. Strong communication, and supervisory capabilities are essential for coordinating study teams and delivering high-quality

Qualifications

• Bachelor's degree in Biostatistics or higher
• Typically requires 6 years of relevant experience
• Advanced knowledge of related job areas through education and experience
• Excellent written and oral communication skills including technical writing
• Familiarity with regulatory requirements (GCP/ICH) and CDISC/ADaM knowledge

Responsibilities

• Lead statistical analyses and QC outputs per SOPs
• Manage statistical team activities and coordinate with project teams
• Review data management designs, validation checks and datasets
• Develop and QC SAPs, datasets, TLFs and documentation
• Monitor timelines, budgets and risk management across studies
• Mentor junior staff and share knowledge across teams

Skills

SAS

R

CDISC/ADaM

QC

SDTM

Education

Bachelor's Degree Biostatistics

Master's Degree Biostatistics

Ph.D. Biostatistics

Tools

nQuery

SAS computing package

Job description

Experience : 7+ Years

Skill : must have Haematological, oncology, liquid tumor.

Location : Across PAN India

Job Overview

We are seeking a statistician with strong experience in Medical Affairs (MAF) and Real-World Evidence (RWE) studies, including practical application of the Estimands framework. The candidate should be proficient in SAS and/or R programming and possess a solid understanding of CDISC standards (ADaM and SDTM). The position is intended for a candidate based in China, and experience with AI tools or AI-driven methodologies would be an added advantage.

The candidate should have the ability to efficiently perform quality control of a large volume of statistical outputs, ensuring consistently high standards of accuracy, quality, and compliance.

• Must have: Oncology experience, CDISC standards experience, QC from STDM data, Haematological malignancies experience (i.e., multiple myeloma, leukaemia, lymphoma, liquid tumor ) and strong communication skills
• Nice to have: lead study statistician in a cross-functional team, statistical design knowledge/experience

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 statistical team 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 statistical discussions, providing support and/or guidance for statistical 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. As a lead, will have input on estimate at completion (EAC) reporting.
• 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: Authors or 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 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, suggest work may be out of scope.
• Financials: Shares accountability (with resource managers) for the financial success of assigned studies. Accountable for controlling costs and maximizing revenue recognition. Responsible for sharing budget expectations with the team. Raises concerns to manager if new work or rework appears to be out of scope. Understands 'scope of work' and has an awareness of contract and budget assumptions.
• 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.
• Other Clinical Data Interchange Standards Consortium (CDISC) requirements: Leadership: Under supervision within Compound. May perform statistical team lead role on studies within a compound. In addition to the leadership responsibilities above, also prioritizes and takes proactive approach to gain efficiencies in work across protocols.
• Study Start up: Assist with protocol development, sample size calculation, protocol and case report form (CRF) review.
• Protocol: Authors or 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).
• Proposals: May be able to review and comment on proposals/budgets at a study level. May contribute to request for proposals (RFP). May be expected to present at bid defenses.
• Clinical Study Report (CSR): Reviews or drafts 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.
• Other Responsibilities: As defined on ad-hoc basis by managers. May assist with cross functional collaboration.

Qualifications

• Bachelor's Degree Biostatistics or Master's Degree Biostatistics or Ph.D. Biostatistics or related field
• Typically requires 6 years of prior relevant experience, or equivalent combination of education, training and experience.
• Requires advanced knowledge of job area, and broad knowledge of a other related job areas, 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 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 Clinical Data Interchange Standards Consortium CDISC/ADaM).