Novotech has announced a new Clinical Data Programmer I (SDTM) job in Bangalore for candidates interested in clinical data programming, SAS and CDISC standards. The full-time opportunity is suitable for early-career professionals with 6 months to 2 years of SDTM programming experience and an educational background in life sciences, computer science, mathematics, statistics or another quantitative/analytical discipline.

As a global full-service clinical Contract Research Organization (CRO), operates a Biometrics function spanning data management, database programming, statistical programming, biostatistics and pharmacometrics. Novotech also confirms that its statistical programming services include regulatory submission standards such as SDTM and ADaM datasets, Define documents, Reviewer’s Guides and Pinnacle 21.

Novotech Clinical Data Programmer Job Overview

Novotech lists its Bangalore office at Ground Floor, Unit 1, Block E, Helios Business Park, Bangalore 560103, India.

About the Clinical Data Programmer I (SDTM) Role

The Clinical Data Programmer I at Novotech is responsible for SDTM programming based on clinical protocols, electronic Case Report Forms (eCRFs) and Statistical Analysis Plans (SAPs).

The Clinical Programmer works with biostatisticians, statistical programmers and other clinical project stakeholders to transform raw clinical trial data into high-quality, standardized CDISC SDTM datasets.

The position can also involve preparing data submission packages and supporting documentation for clients and regulatory authorities.

Key Responsibilities

Selected candidates will be responsible for:

• Performing SDTM programming and SDTM CRF annotation.
• Programming and validating datasets from raw clinical data into SDTM format.
• Conducting SDTM quality control, double programming and peer reviews.
• Developing Define.xml, Reviewer’s Guides and regulatory submission documents.
• Following statistical programming standards, conventions and clinical data standards.
• Ensuring SAS programs are appropriately documented and traceable.
• Validating SAS datasets using Pinnacle 21.
• Maintaining clinical study documentation, programs and project files.
• Maintaining accurate work records and timesheets.
• Participating in departmental meetings and collaborative project activities.

Novotech’s Biometrics services similarly cover statistical planning, analysis, regulatory submissions and reporting, including SDTM datasets, Define documents and Reviewer’s Guides.

Qualification – Which Degrees Can Apply?

According to the supplied Novotech job description, applicants should possess a Bachelor’s degree in Life Sciences, Computer Science, Mathematics, Statistics, or a Quantitative/Analytical field.

Depending on the specific discipline and recruiter screening, relevant educational backgrounds may include:

B.Pharm / B.Sc Life Sciences / B.Sc Biotechnology / B.Sc Microbiology / B.Sc Biochemistry / B.Sc Computer Science / BCA / B.Tech / B.E. / B.Sc Mathematics / B.Sc Statistics / Data Science or related quantitative and analytical degrees.

Candidates should note that the employer’s stated requirement is field-based rather than a definitive list of individual degree titles. Novotech separately identifies Pharmacy and life-science graduates as eligible educational backgrounds for its Clinical Data Programmer–SAS Trainee program.

Experience Required

Candidates should have approximately 6 months to 2 years of programming experience specifically involving SDTM concepts.

Previous experience within a pharmaceutical company, Contract Research Organization (CRO), clinical research organization or related environment is desirable.

This makes the Novotech Clinical Data Programmer I opening particularly relevant to early-career candidates who already have hands-on SDTM/SAS programming exposure.

Skills Required for Novotech SDTM Programmer

Candidates should have knowledge or experience in:

• SAS programming
• CDISC standards
• SDTM and SDTMIG
• Controlled terminology
• SDTM dataset creation and validation
• Clinical protocols
• Statistical Analysis Plans
• Pinnacle 21
• Clinical trial data
• Laboratory and adverse event data
• Regulatory requirements
• R programming
• Strong attention to detail
• Organizational skills

SAS certification is recommended in the supplied job description, rather than explicitly stated as mandatory.

Why Consider a Clinical Data Programming Career at Novotech?

The role provides exposure to clinical data standards, SAS programming, CDISC SDTM, regulatory submissions and clinical research data.

Novotech states that its Biometrics organization works across data management, database programming, statistical programming, biostatistics and pharmacometrics. Its careers information also highlights structured training, career development and support from managers, senior leaders and clinical experts.

For candidates planning careers in Clinical SAS Programming, Statistical Programming, Clinical Data Programming or CDISC programming, this position provides relevant industry exposure.

Employee Benefits

According to the supplied job description, Novotech highlights benefits and workplace initiatives including:

• Flexible working options
• Paid parental leave for both parents
• Flexible leave entitlements
• Wellness programs
• Ongoing professional development programs
• Mentorship and career development opportunities
• Inclusive workplace initiatives
• Work-life balance support

Novotech’s official careers information similarly describes flexible working options, professional development, training and its NovoLife flexible benefits framework.

How to Apply

Application Link