Senior Specialist - SAS Programmer

Syngene International; Bengaluru; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

Syngene International is seeking a Senior Specialist, Clinical Trials - SAS programming in Bengaluru, India. The role sits in Biostatistics and SAS Programming, focusing on converting clinical data into SDTM/ADaM datasets and generating TFL outputs per SAP.

The ideal candidate has 3-4 years of SAS programming experience in clinical trials, with proficiency in Base SAS, SAS/SQL, MACROS, and domain knowledge across phase I–IV studies. A relevant technical degree is required.

Qualifications

• 3-4 years of SAS programming experience in clinical trials.
• Proficiency in Base SAS, SAS/SQL, MACROS and SDTM/ADaM datasets.
• Experience with Phase I-IV studies and data standards.
• Bachelor’s degree in technology, pharmacy or related field; or equivalent degree.

Responsibilities

• Build and transform SAS datasets from clinical databases and CRF annotations per SAP.
• Develop SDTM/ADaM datasets and CDISC-compliant outputs.
• Create standardized SAS macros and templates for data handling.
• Develop and validate SAS programs to generate tables, listings, and figures per protocol.

Skills

Base SAS

SAS/SQL

Macros

Clinical domain

Education

Bachelor of Technology

Bachelor of Pharmacy

Any Degree (B.Com, B.Sc)

Tools

Pinnacle 21 Validation

SDTM/ADaM

Job description

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Job Title: Senior Specialist, Clinical Trials - SAS programming.

Department: Biostatistics and SAS Programming

About Syngene: Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company's integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity,health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene's quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the Role: To perform Clinical Sas Programming activities in Biometrics and SAS programming Department for Bio-availability and Bio-equivalence & Clinical Studies Phase 1-4

Role Accountabilities

• Build and transform SAS datasets from clinical databases, external sources, and CRF annotations in alignment with protocol and Statistical Analysis Plan (SAP) specifications.
• Implement CDISC standards such as SDTM and ADaM datasets.
• Developing standardized macros and templates for streamlined data handling.
• Develop and validate SAS programs to generate tables, listings, and figures (TFLs) in line with protocol requirements and reporting standards.
• Perform QC on SAS code and output datasets, TLFs, and derived summaries—to ensure accuracy and compliance
• Program and validate edit checks per Data Validation and Data Management Plans to maintain data integrity.
• Any other responsibilities assigned by the organization from time to time.

All employees will consistently demonstrate alignment with our core values

• Integrity
• Professionalism

Specific requirements for this role

• Experience: 3-4 Years
• Demonstrated Capability
• Experienced in Base SAS, SAS/SQL, MACROS and Clinical domain (Specification development, Anotation of CRF, Pinnacle 21 Validation, SDTM and ADaM datasets development and Submission Package).
• Clinical Trials Exposure -Phase I-IV studies with Good Experience
• Education: Bachelor of Technology, Bachelor of pharmacy or Any Degree (B.com, B.sc)

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.