SAS Programmer & Biostatistician

Syngene International Limited; Bengaluru Urban; Presencial; INR 1 200 000 - 1 800 000; Tempo integral

Resumo da oferta

Syngene International Limited, located in Bengaluru, is seeking a Senior Specialist in SAS Programming & Biostatistician to perform clinical SAS programming for Bio-availability and Bio-equivalence studies through Phase 1-4. The role requires 3-8 years of experience and strong expertise in SAS, SDTM/ADaM, and CDISC standards.

You will build and validate SAS datasets, develop TFLs, create macros, and ensure data integrity aligned with SAP and regulatory requirements.

Qualificações

• 3-8 years of SAS programming and biostatistics experience in clinical studies.
• Experience with SDTM/ADaM data standards and CBIS submissions.
• Proficiency in SAS programming, macros, and data management.
• Knowledge of Pinnacle 21 validation is desirable.

Responsabilidades

• Build and transform SAS datasets from clinical databases, external sources, and CRF annotations as per SAP.
• Develop and validate SAS programs to generate TFLs in line with protocol and reporting standards.
• Implement CDISC standards such as SDTM and ADaM.
• Create standardized macros and templates for data handling.

Conhecimentos

Base SAS

SAS/SQL

Macros

Clinical domain knowledge

Pinnacle 21 validation

Formação académica

B.Tech

B.Pharm

Any Degree

Ferramentas

SDTM

ADaM

Descrição da oferta de emprego

Date: 23 Oct 2026

Location: IN

Division: Discovery Services

Job Title: Senior Specialist, SAS Programmer & Biostatistician

Job Location: Semicon Park, Bangalore

Department: BDM (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.

Experience:

3-8 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 accommodation for qualified individuals with disabilities.