About this role
JOB DESCRIPTION
Job Title: Senior Specialist, Clinical Trials - SAS programming.
Job Location: Bangalore
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.
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- 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.