Biostatistician

RemoteJobsOne; Manila; Remote; PHP 5,192,000 - 5,625,000; Full time

Job summary

RemoteJobsOne is seeking a Biostatistician for a fully remote contractor role focused on AI-assisted clinical research. You will apply clinical statistics expertise to train next-generation AI systems, shaping how models learn and reason with real-world data.

The role requires strong SDTM/ADaM experience, SAS/R proficiency, and a MSc/PhD in Biostatistics or closely related field. Prior leadership on pivotal studies and oncology endpoints is a plus.

Qualifications

• 5+ years as a biostatistician supporting clinical trials.
• Experience producing/quality controlling TFLs for regulatory submissions from CDISC SDTM/ADaM datasets.
• Expertise in estimands, missing-data strategies and multiplicity control per ICH E9(R1).
• Proficiency in SAS or R and reproducing analyses from specifications.
• Ability to interpret SAPs and align results with pre-specified analyses.
• Nice to have: lead statistician on pivotal studies and oncology endpoints; AI-assisted tools.

Responsibilities

• Author and review evaluation tasks deriving or validating statistical outputs from clinical datasets and TFLs.
• Assess correctness and consistency of estimates, CIs, p-values, populations, and missing data handling.
• Identify discrepancies between outputs and CSR narratives, including population definitions and rules.
• Document the derivation process to enable independent verification.
• Provide structured rationales distinguishing true errors from alternatives.
• Collaborate with the project team to refine evaluation tasks and criteria.

Skills

Biostatistics

SAS

R

Survival analysis

Missing data

Education

MSc/PhD in Biostatistics or related

Tools

CDISC SDTM/ADaM

Job description

This is a fully remote position, open to candidates based in Philippines.

Pay: $60–$65/hr

Role Title: Biostatistician

Role Type: Contractor

Location: Remote

We are engaging Biostatisticians to contribute their clinical statistics expertise to a dynamic customer project focused on AI-assisted clinical research. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.

Scope of Work

1. Author and review evaluation tasks that require deriving, reproducing, or validating statistical outputs from clinical datasets and associated tables, figures, and listings (TFLs).
2. Apply expert judgment to assess the correctness and consistency of reported estimates, confidence intervals, p-values, analysis populations, and missing data handling in alignment with the statistical analysis plan (SAP).
3. Identify discrepancies between statistical outputs and their narrative descriptions in clinical study reports (CSR), including subtle errors in population definitions, censoring rules, or multiplicity handling.
4. Establish defensible ground truth for each evaluation task, documenting the derivation process to enable independent verification.
5. Provide structured written rationales distinguishing true statistical errors from acceptable methodological alternatives, employing clear and concise communication.
6. Collaborate with a multidisciplinary project team, providing statistical insights and feedback as needed to refine evaluation tasks and criteria.

Preferred Qualifications

1. 5+ years as a biostatistician supporting clinical trials at a sponsor, CRO, or academic trials unit.
2. Hands‑on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets.
3. Solid understanding of statistical methods used in confirmatory trials, including survival analysis, mixed models, covariate adjustment, multiplicity control, and estimand and missing-data strategies under ICH E9(R1).
4. Proficiency in SAS and/or R, with the ability to independently reproduce analyses from written specifications.
5. Ability to interpret SAPs and ensure reported results are consistent with pre‑specified analyses.
6. Advanced degree (MSc or PhD) in Biostatistics, Statistics, or a closely related quantitative field.
7. Nice to have: Experience as lead statistician on pivotal/registrational studies, authoring or reviewing CSR statistical sections, oncology endpoint expertise, and exposure to AI‑assisted statistical review tools.