Senior Clinical

6 hours ago

Singapur, Singapore PRESTIGE BIOPHARMA LIMITED Full time

Senior Clinical / Medical Biostatistician Location: Singapore/Remote Department: Clinical Development / Biostatistics Reports to: Head of Biostatistics / Clinical Development Lead Role Summary We are seeking an experienced Senior Biostatistician to provide both strategic and hands-on statistical leadership across our biosimilar and innovative biologic programs. The role includes clinical trial design, PK/PD and immunogenicity assessments, regulatory submissions, vendor oversight, and direct involvement in statistical programming and data review. This position requires strong technical capability, experience working with cross-functional study teams, and the ability to operate in a fast-moving biotech environment. Key Responsibilities Strategic & Scientific Lead statistical planning for Phase I–III studies, including biosimilar PK similarity studies, immunogenicity evaluation, and novel biologic trials. Provide statistical input to clinical protocols (design, endpoints, sample size, randomization). Develop and review SAPs, mock shells, and dataset specifications. Support regulatory submissions (CTD Modules 2 & 5) and respond to agency queries. Participate in scientific discussions and support HA/advisory meetings. Statistical Analysis & Programming Perform and oversee analysis using SAS/R, including TLFs and complex models (mixed, survival, exposure-response). Support development and QC of SDTM/ADaM datasets. Develop/validate SAS macros and utilities to streamline workflows. Review CRF annotations and data specifications. Biosimilar Focus Design and analyze PK/BA/BE studies including parallel, crossover, and replicated designs. Interpret PK/PD, immunogenicity and safety similarity data. Support equivalence margin justification and regulatory expectations for biosimilars. Cross-functional & Vendor Management Oversee CRO biostatistics and programming deliverables; ensure compliance with quality and timelines. Collaborate closely with Clinical Operations, Data Management, Medical Writing, Regulatory, PV. Train and mentor junior biostatisticians; contribute to building internal biostats capability. Ensure statistical accuracy, data integrity and audit readiness. Qualifications MSc/PhD in Biostatistics/Statistics or related field. ~5–7+ years of clinical biostatistics experience in pharma/CRO/biotech. Strong hands-on SAS and/or R programming skills. Experience with clinical PK/PD, immunogenicity, and BA/BE trial designs. Working knowledge of CDISC (SDTM/ADaM) and ICH-GCP. Experience supporting regulatory submissions and interacting with health authorities. Preferred Experience in oncology and/or biologics. Knowledge of Phoenix WinNonlin and exposure-response analysis. Experience with adaptive designs and/or Bayesian methods. Competencies Strong analytical judgment and problem-solving mindset. Ability to translate statistical results for non-statistical stakeholders. Excellent communication and teamwork skills. Adaptability to a fast-paced biotech environment with evolving priorities. What We Offer Opportunity to contribute to biosimilar and novel biologics programs. Hands-on role with direct scientific impact. Collaborative culture with career growth and skill-building opportunities. #J-18808-Ljbffr

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