Biostatistician

RemoteJobsOne; Paris; À distance; EUR 73 000 - 79 000; Plein temps

Résumé du poste

RemoteJobsOne is seeking a Biostatistician to contribute clinical statistics expertise to AI-assisted clinical research. This fully remote role is open to candidates based in France.

The ideal candidate has 5+ years in clinical trials, proficiency in SAS/R, and experience with CDISC SDTM/ADaM datasets, SAP interpretation, and regulatory submissions. Collaboration with a multidisciplinary team is essential.

Qualifications

• 5+ years as a biostatistician supporting clinical trials.
• Experience producing or quality controlling TFLs for regulatory submissions from SDTM/ADaM datasets.
• Strong knowledge of survival analysis, mixed models, multiplicity control, estimand and missing-data strategies under ICH E9(R1).
• Proficiency in SAS and/or R; able to reproduce analyses from written specifications.
• Ability to interpret SAPs and ensure results align with pre-specified analyses.

Responsabilités

• Author and review evaluation tasks deriving, reproducing, or validating statistical outputs from clinical datasets and TFLs.
• Assess correctness and consistency of reported estimates, CIs, p-values, analysis populations, and missing data handling per the SAP.
• Identify discrepancies between outputs and CSR narratives, including population definitions and censoring rules.
• Establish defensible ground truth and document derivation for verification.
• Provide structured rationales distinguishing true errors from acceptable alternatives.
• Collaborate with the project team to refine evaluation tasks and criteria.

Connaissances

Biostatistics

SAS

R

Clinical trials

Interpret SAPs

Survival analysis

Missing data handling

Formation

Advanced degree (MSc or PhD) in Biostatistics or related field

Outils

CDISC SDTM/ADaM

SAS

R

Description du poste

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

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.