Senior / Principal Biostatistician – Phase I Clinical Trials

Position Summary

Tech Observer is seeking a highly skilled Senior or Principal Biostatistician with experience in Phase I clinical trials and early clinical development. The successful candidate will provide statistical expertise in clinical study design, protocol development, statistical analysis planning, data analysis, and interpretation of clinical trial results, with a focus on safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD).

Key Responsibilities

- Provide statistical expertise in the design and conduct of Phase I clinical trials, including first-in-human, single ascending dose (SAD), multiple ascending dose (MAD), and other early-phase studies.
- Contribute to clinical study protocols, including study objectives, endpoints, sample size considerations, randomization, and statistical methodology.
- Develop, review, and finalize Statistical Analysis Plans (SAPs) in accordance with study protocols and applicable regulatory requirements.
- Perform and interpret statistical analyses for safety, tolerability, PK/PD, and other relevant clinical endpoints.
- Support dose-escalation studies, dose proportionality assessments, exposure-response analyses, and dose-selection decisions in collaboration with clinical and pharmacology teams.
- Review statistical outputs, including tables, listings, and figures (TLFs), and ensure the accuracy and consistency of statistical deliverables.
- Contribute to Clinical Study Reports (CSRs) and other clinical development and regulatory documentation.
- Collaborate with clinical operations, clinical pharmacology, data management, statistical programming, and other cross-functional teams.
- Ensure statistical analyses and documentation comply with applicable ICH guidelines, Good Clinical Practice (GCP), and relevant regulatory standards.
- Review statistical programming outputs and provide quality oversight of statistical deliverables.

Required Qualifications





- Master's or PhD in Biostatistics, Statistics, or a related quantitative discipline.
- Robust experience in biostatistics within the pharmaceutical, biotechnology, or clinical research industry.
- Hands-on experience supporting Phase I or early-phase clinical trials.
- Demonstrated expertise in clinical study design, statistical methodology, SAP development, and interpretation of clinical data.
- Proficiency in SAS; experience with R is an advantage.
- Knowledge of CDISC standards, including SDTM and ADaM.
- Understanding of ICH-GCP and clinical trial regulatory requirements.
- Strong analytical, problem-solving, communication, and documentation skills.

Preferred Qualifications

- Experience with first-in-human studies, SAD/MAD designs, and dose-escalation trials.
- Experience in safety and tolerability assessments, PK/PD analyses, dose proportionality, and exposure-response modeling.
- Familiarity with model-based or Bayesian approaches to dose escalation, where applicable.
- Experience contributing to clinical study reports and regulatory submissions.
- Ability to work independently and collaborate effectively with multidisciplinary teams.

Experience Expectations

- Senior Biostatistician: Typically 5–8+ years of relevant experience, including Phase I clinical trial support.
- Principal Biostatistician: Typically 8–12+ years of relevant experience, with independent statistical leadership, methodological expertise, and cross-functional collaboration.

Ideal Candidate Profile The ideal candidate will combine strong statistical fundamentals with practical experience in early-phase clinical development. Candidates should be able to independently contribute to study design, statistical analysis planning, data interpretation, and regulatory-ready deliverables. Recruiter screening priority: Prioritize candidates with direct Phase I clinical trial experience, particularly SAD/MAD, first-in-human studies, safety and tolerability analyses, and PK/PD. General clinical-trial biostatistics experience without early-phase exposure may not be sufficient.

📌 Principal Biostatistician-Phase I (FSP) (Mumbai)
🏢 Tech Observer
📍 Mumbai