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Cdisc Sdtm Adam Jobs in Indiana (NOW HIRING)

micro1 AI

Biostatistician

Indianapolis, IN · Remote

$60 - $65/hr

Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets. * Solid understanding of statistical methods used in ...

micro1 AI

Director of Biostatistics

Evansville, IN · Remote

$60 - $65/hr

Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets. * Solid understanding of statistical methods used in ...

micro1 AI

Director of Biostatistics

Fishers, IN · Remote

$60 - $65/hr

Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets. * Solid understanding of statistical methods used in ...

micro1 AI

Biostatistician

Fishers, IN · Remote

$60 - $65/hr

Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets. * Solid understanding of statistical methods used in ...

micro1 AI

Director of Biostatistics

Indianapolis, IN · Remote

$60 - $65/hr

Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets. * Solid understanding of statistical methods used in ...

micro1 AI

Director of Biostatistics

Carmel, IN · Remote

$60 - $65/hr

Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets. * Solid understanding of statistical methods used in ...

micro1 AI

Biostatistician

Carmel, IN · Remote

$60 - $65/hr

Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets. * Solid understanding of statistical methods used in ...

micro1 AI

Biostatistician

South Bend, IN · Remote

$60 - $65/hr

Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets. * Solid understanding of statistical methods used in ...

micro1 AI

Director of Biostatistics

Fort Wayne, IN · Remote

$60 - $65/hr

Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets. * Solid understanding of statistical methods used in ...

micro1 AI

Director of Biostatistics

South Bend, IN · Remote

$60 - $65/hr

Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets. * Solid understanding of statistical methods used in ...

micro1 AI

Biostatistician

Evansville, IN · Remote

$60 - $65/hr

Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets. * Solid understanding of statistical methods used in ...

micro1 AI

Biostatistician

Fort Wayne, IN · Remote

$60 - $65/hr

Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets. * Solid understanding of statistical methods used in ...

All JobsCdisc Sdtm Adam JobsCdisc Sdtm Adam Jobs in Indiana

Cdisc Sdtm Adam information

What are CDISC SDTM and ADaM?

CDISC SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) are data standards used in clinical trials to organize and submit data to regulatory agencies like the FDA. SDTM defines how to structure raw clinical trial data for submission, focusing on standardizing data tabulation. ADaM provides guidelines for creating datasets used in statistical analysis, ensuring the data is analysis-ready and traceable back to SDTM. Both standards improve data quality, consistency, and regulatory review efficiency in the pharmaceutical industry.

What are the typical collaboration points between a CDISC SDTM/ADaM programmer and clinical data managers during a clinical trial project?

A CDISC SDTM/ADaM programmer works closely with clinical data managers to ensure data collected during a clinical trial is accurately mapped and transformed according to regulatory standards. Collaboration often involves clarifying data definitions, resolving data discrepancies, and aligning on timelines for data delivery. Regular meetings and clear communication are key, as programmers rely on data managers for clean, validated data, while data managers depend on programmers to structure data sets correctly for analysis and regulatory submission. This partnership is essential for meeting project deadlines and maintaining data integrity.

What are the key skills and qualifications needed to thrive as a CDISC SDTM/ADaM specialist, and why are they important?

To thrive as a CDISC SDTM/ADaM Specialist, you need a solid background in clinical data management, knowledge of regulatory standards, and expertise in statistical programming (often with SAS). Familiarity with CDISC SDTM and ADaM models, FDA submission requirements, and tools like Pinnacle 21 or JReview is typically required. Strong attention to detail, analytical thinking, and effective communication are essential soft skills for this role. These competencies ensure accurate data standardization, regulatory compliance, and smooth collaboration in clinical research environments.

What is the difference between Cdisc Sdtm Adam vs Clinical Data Coordinator?

AspectCdisc Sdtm AdamClinical Data Coordinator
Primary RoleDevelops and manages ADaM datasets for clinical trialsOversees data collection, entry, and quality control in clinical studies
Required SkillsKnowledge of CDISC standards, SAS programming, statistical conceptsData management, database systems, attention to detail
Work EnvironmentPharmaceutical or CRO data analysis teamsClinical research sites, CROs, pharmaceutical companies

While Cdisc Sdtm Adam specialists focus on creating analysis datasets using CDISC standards, Clinical Data Coordinators manage the overall data collection and quality in clinical trials. Both roles require knowledge of clinical data processes but differ in their specific responsibilities and technical focus.

What are popular job titles related to Cdisc Sdtm Adam jobs in Indiana?

For Cdisc Sdtm Adam jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Cdisc Sdtm Adam jobs in Indiana look for?

The top searched job categories for Cdisc Sdtm Adam jobs in Indiana are:

What cities in Indiana are hiring for Cdisc Sdtm Adam jobs?

Cities in Indiana with the most Cdisc Sdtm Adam job openings:

Cdisc Sdtm Adam jobs near you
Infographic showing various Cdisc Sdtm Adam job openings in Indiana as of July 2026, with employment types broken down into 89% Full Time, 9% Part Time, and 2% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution.

Biostatistician

micro1 AI

Indianapolis, IN • Remote

$60 - $65/hr

Part-time

Posted 15 days ago

Job description

Role Title: Biostatistician


Role Type: Contractor


Location: Remote


micro1 is 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.

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