Indero, formerly Innovaderm, is hiring for the position of Statistical Programmer in India. This opportunity is suitable for clinical research professionals with experience in SAS programming, CDISC standards, SDTM, ADaM, TLF programming and clinical trial data.
The Statistical Programmer will work within Biostatistics study teams and collaborate across departments to develop and validate clinical trial programming deliverables. Key responsibilities include programming SDTM and ADaM datasets, Tables, Listings and Figures (TLFs), annotated Case Report Forms (aCRFs), define.xml files and reviewer guides.
Candidates interested in Clinical SAS Programmer jobs, Statistical Programmer jobs in India, CDISC programming jobs, SDTM ADaM jobs and CRO statistical programming careers can review the eligibility criteria below.
Job Overview
| Particular | Details |
|---|---|
| Company | Indero (formerly Innovaderm) |
| Position | Statistical Programmer |
| Industry | Clinical Research / CRO |
| Employment | Permanent, Full-Time |
| Job Level | Professional |
| Location | India |
| Work Model | Home-Based / Remote stated in JD |
| Experience | At least 1 year of clinical research experience, including 1 year in Statistical Programming |
| Key Skills | SAS, SDTM, ADaM, TLFs, CDISC, Pinnacle 21 |
| Qualification | Bachelor’s degree in Statistics, Computing Sciences or related field |
| Master’s Degree | Considered an asset |
About the Statistical Programmer Role
The Statistical Programmer at Indero will support the development, maintenance and validation of statistical programming deliverables used throughout clinical studies.
The role involves working with clinical trial data and producing submission-quality datasets and outputs in accordance with CDISC standards, ICH guidelines, regulatory requirements, sponsor standards and company SOPs.
The Statistical Programmer may contribute to deliverables required for Data Monitoring Committee (DMC) meetings, Interim Analyses (IAs) and Clinical Study Reports (CSRs).
Key Responsibilities
As a Statistical Programmer at Indero, your responsibilities may include:
- Develop, maintain and validate annotated Case Report Forms (aCRFs) using the clinical study protocol, eCRF and applicable CDISC standards.
- Develop and validate specifications for SDTM datasets, ADaM datasets and derived datasets.
- Perform primary or QC statistical programming for SDTM, ADaM and TLF deliverables.
- Program Tables, Listings and Figures (TLFs) according to the protocol, Statistical Analysis Plan (SAP) and approved TLF shells.
- Support Data Management teams with clinical data cleaning activities.
- Program and review statistical data issues and support their resolution and closure.
- Develop and validate SDTM define.xml/define.pdf and ADaM define.xml/define.pdf.
- Prepare and maintain the Clinical Study Data Reviewer’s Guide (cSDRG) and ADaM Reviewer’s Guide (ADRG).
- Validate SDTM datasets, ADaM datasets and define.xml files using Pinnacle 21.
- Review Pinnacle 21 findings and work with Statistical Programmers and Lead Biostatisticians to resolve applicable issues.
- Use global SAS macros to improve programming efficiency.
- Participate in the development and validation of standard SAS macros, templates and programming processes.
- Follow company SOPs, programming standards and applicable regulatory requirements.
- Stay updated with the latest CDISC, ICH and regulatory authority guidelines.
- Review and provide input into eCRFs, edit checks, SAPs and TLF shells when required.
- Potentially serve as a Lead Statistical Programmer on individual studies when appropriately qualified.
Qualification and Eligibility
Candidates applying for the Indero Statistical Programmer position should meet the following requirements:
Educational Qualification
- Bachelor’s degree in Statistics, Computing Sciences or a related field
- A Master’s degree is considered an asset
Candidates should note that the employer has not provided a broad list of alternative degrees. Applicants from related quantitative or computing disciplines should assess whether their education and experience meet Indero’s “related field” requirement.
Experience Required
Indero specifically requires:
- At least 1 year of clinical research experience in the biotechnology, pharmaceutical or CRO industry.
- This should include 1 year of Statistical Programming experience.
- Candidates should have meaningful exposure to clinical trial data, Statistical Analysis Plans (SAPs), TLF shells and programming specifications.
Therefore, this position should not be represented as a pure fresher Statistical Programmer opening based on the supplied official requirements.
Technical Skills Required
Candidates should have strong knowledge or experience in:
- SAS Programming
- Clinical SAS
- CDISC standards
- SDTM
- ADaM
- TLF programming
- Clinical trial datasets
- Statistical programming specifications
- SAPs
- TLF shells
- Pinnacle 21
- aCRF annotation
- define.xml
- cSDRG
- ADRG
- Clinical data cleaning
- SAS macros
Knowledge of XML programming is considered an advantage.
A SAS certification and/or CDISC certification may also strengthen the candidate’s profile, although the job description lists these as assets rather than mandatory requirements.
Regulatory and Clinical Research Knowledge
Applicants are expected to understand the drug development process and relevant clinical research standards, including:
- ICH guidelines
- ICH E6
- ICH E9
- ICH E9(R1)
- FDA regulations and guidance
- Health Canada requirements
- Electronic clinical data submission requirements
- Pharmaceutical Industry Good Programming Practices (GPP)
This regulatory knowledge is particularly important because statistical programming outputs may ultimately support clinical study reporting and regulatory submissions.
Preferred Professional Skills
Along with technical Statistical Programming expertise, Indero is seeking candidates who are:
- Highly organized and detail-oriented
- Effective at project planning
- Strong in time management
- Comfortable handling multiple competing priorities
- Capable of working independently
- Effective collaborators in cross-functional teams
- Strong verbal and written communicators in English
Knowledge of French is considered an asset.
Employee Benefits
According to the supplied Indero job description, the Statistical Programmer will be eligible for:
- Permanent full-time employment
- Flexible work schedule
- Home-based working arrangement
- Ongoing learning and development
- Career advancement opportunities
- Exposure to global clinical research projects
- Collaboration with Biostatistics, Data Management and other clinical research functions
Estimated Salary
The official job description does not disclose compensation.
For structured-data purposes only, a reasonable market estimate for a Statistical Programmer with approximately 1+ years of relevant clinical programming experience in India may be around:
₹5,00,000 – ₹10,00,000 per year
This is an estimated market range, not an Indero-published salary. Actual compensation can vary considerably depending on SAS/CDISC expertise, experience, location, responsibilities and the employer’s compensation structure.
Why This Role Can Be Valuable for Clinical SAS Professionals
This position offers hands-on exposure across several important areas of modern clinical statistical programming, including SDTM, ADaM, TLFs, CDISC standards, Pinnacle 21 validation and regulatory submission deliverables.
Professionals building careers as Clinical SAS Programmers, Statistical Programmers, Senior Statistical Programmers or Statistical Programming Leads can gain relevant end-to-end clinical development exposure through this type of role.