IQVIA | Biostatistician III

Role : Biostatistician III Skill : SAP, Clinical trials
Mode : Homebased
Experience : 8- 15 years
Job Location : PAN India
Educational Qualification : Master's in Statistics or Ph.D. in Statistics
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.
Roles & Responsibilities:
Ability to work successfully within a global cross-functional teams leading to successful regulatory filings and approvals.  Excellent verbal and written communications skills.  Ability to be flexible and adapt quickly to the changing needs of the organization.  Ability to organize multiple work assignments and establish priorities.  Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization, and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.
Additional Key Responsibilities and Duties:
Independently leads the development and execution of statistical aspects for studies of low to moderate complexity.
Participates in PRC reviews of study protocols and SAPs.
Provide data interpretation for study documents, e.g., CSR.
Contributes to preparation of the development strategy that will allow for effective and safe utilization of the product.
Develops trial designs that address study objectives that will support regulatory approval and market access.
Translates scientific questions into statistical terms and statistical concepts into layman terms.
Challenges collaborator assumptions and positions based on facts and provide insights and perspective based on available information.
Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis.
Communicates effectively with clinical and regulatory partners and external opinion leaders.
Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents.
Exercises cost-disciplined science in sizing of the trials and in the planning for the analyses to be conducted.
Compliant with processes and SOPs, global and project standards, and responsible for quality of deliverables
Ensures programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information.
Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents and scientific articles.
Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team.
Drives alignment at study team level, and escalates lack of team alignment to the GBDS Lead for resolution.
Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions.
Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.
Keeps up to date with state-of-the art applied statistical methodology.
Understanding of CDISC standards and implementation guides.
Professional or Other Attributes :
Strong interpersonal and communication skills, effective team player and able to work with individuals at all levels within the organization and build remote relationships.
Excellent English skills and experience of working within multi-location team.
Excellent prioritization skills, works well under pressure and ability to multi-task.
Ability to work independently with minimal supervision and to resolve problems on non-routine matters.

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