Analyst Biostatistics and Programming

JOB DESCRIPTION

Job Title: Analyst - Biostatistics and Programming 

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.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence


•  Integrity


•  Professionalism

Accountabilities as a Syngene Leader (only for Leadership Hires)

• Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities.


• Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance.

• Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.

Specific requirements for this role

1. Experience: Entry

2. Demonstrated Capability

Good Knowledge in Base SAS, SAS/SQL, MACROS and Clinical domain (SDTM and ADaM).

        Clinical Trials Exposure –Phase I-IV studies with Good Knowledge

3. 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.