Biostatistics Roles – Mid-Sized Biotech

3 days ago

Singapore PRESTIGE BIOPHARMA PTE. LTD. Full time $60,000 - $120,000 per year
Junior Clinical / Medical Biostatistician

Location: Singapore/Remote

Department: Clinical Development / Biostatistics

Reports to: Senior / Lead Biostatistician

Role Summary

We are seeking a motivated Junior Biostatistician to join our rapidly growing biotech organisation focused on developing both biosimilars and novel biologics. This role will support statistical design, analysis, and reporting for early- and late-phase clinical programs, working closely with cross-functional teams including clinical operations, regulatory, medical affairs, pharmacovigilance, and data management.

Key Responsibilities

  • Support statistical input for clinical trial protocols, including sample-size calculations, endpoints, study design, and randomisation.

  • Assist in developing Statistical Analysis Plans (SAPs), table shells, and methodology.

  • Conduct analyses and prepare TLFs for reviews and CSRs.

  • Collaborate in preparing SDTM/ADaM datasets in partnership with data management/programming.

  • Contribute to CRO oversight and QC of biostatistical deliverables.

  • Assist in preparing PK and immunogenicity analyses for biosimilar programs.

  • Learn regulatory expectations (FDA/EMA/HSA) for biosimilar clinical similarity.

  • Participate in team meetings and support cross-functional decisions.

Qualifications

  • Bachelor's/Master's in Biostatistics/Statistics or related field

  • Internship or 0–2 years in clinical research or statistical role

  • SAS or R proficiency (or willingness to learn quickly)

  • Strong analytical and communication skills

**Preferred**

  • Exposure to CDISC datasets (SDTM/ADaM)

  • Experience with biologics, immunotherapy, or biosimilars

  • Interest in PK, ADA/NAb, and equivalence testing

Key Competencies

  • Learning mindset, agility, teamwork, scientific curiosity

What We Offer

  • Exposure to biosimilar & novel biologic programs

  • Structured mentorship & growth pathway

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