Senior Clinical / Medical Biostatistician

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.