Senior Clinical

3 days ago

Singapore PRESTIGE BIOPHARMA PTE. LTD. Full time $120,000 - $180,000 per year
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.

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