Job Title

Job Title :- BiostatisticianReports to :- Vice President India OperationsJOB PurposeThe Biostatistician provides advanced statistical leadership and oversight across multiple clinical studies. This role is responsible for study design, statistical analysis, regulatory support, and cross‑functional collaboration. The Senior Biostatistician will serve as the primary point of contact for all assigned studies and will directly interface with the US team, ensuring smooth communication and timely delivery of all statistical milestones. 2. DUTIES AND RESPONSIBILITIES1. Study Design & Statistical PlanningProvide statistical input into study protocols, including sample size estimation, randomization design, and selection of appropriate statistical methodologies.Develop and review Statistical Analysis Plans (SAPs) and table/figure/listing (TFL) shells.Ensure study designs align with regulatory expectations and scientific feasibility.2. Milestone Setting & Project CoordinationEstablish detailed statistical milestones for all assigned studies (e.g., SAP finalization, programming timelines, data cut-off points, interim analyses, and submission deadlines).Track progress and ensure timely notifications to all relevant team members regarding:Upcoming submissionsStudy meetingsDeliverable deadlinesCritical dependencies affecting timelinesProactively identify risks and implement mitigation plans to avoid delays.3. Primary Point of ContactServe as the primary contact for all statistical matters for assigned studies.Act as the main liaison for the US team, ensuring consistent communication, expectation alignment, and delivery of high‑quality outputs.Represent the biostatistics function in internal meetings, sponsor meetings, and cross‑functional discussions.4. Statistical Analysis & ReportingLead statistical analyses using SAS/R within the ADaM and CDISC framework.Validate and review outputs generated by statistical programmers.Author and review statistical sections of clinical study reports (CSRs), publications, and regulatory responses.Provide clear statistical interpretation and recommendations to clinical and regulatory stakeholders.5. Regulatory & Compliance SupportSupport submissions to regulatory agencies (FDA, EMA, MHRA, etc.).Ensure compliance with ICH E6/E9, GCP, CDISC standards, and other regulatory/statistical guidelines.Contribute to responses to regulatory queries and prepare briefing materials when needed.3.QUALIFICATIONSMaster’s or PhD in Biostatistics, Statistics, or related quantitative discipline.Typically, 5–8 years of experience as a Biostatistician in pharmaceutical, biotech, or CRO environments.Proven experience handling multiple studies independently and leading cross‑functional communication.Proficiency in SAS (required).Strong understanding of clinical trial methodologies and statistical modeling.Experience with CDISC standards (SDTM, ADaM) and regulatory expectations.Excellent verbal and written communication skills (especially for US stakeholder interaction).Strong project management and timeline‑tracking abilities.Ability to independently drive studies and collaborate effectively across functions.4. WORKING CONDITIONSThis position operates in an office setting,in person.Job may additionally require incumbent to be available outsideof these hours to handle priority business needs.5. PHYSICAL REQUIREMENTSThis is a largelysedentary role.6. DIRECT REPORTSN/A