Biostatistician

JOB DESCRIPTION

Job Title: Executive-Biostatistician

Department: BDM (Biostatistics and Programming)

Job Location: Semicon Park Bangalore

About Syngene: Syngene () 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 companys 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 integrityhealth 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 Biostatistical activities in Biometrics Department for Clinical Studies Phase 1-4

Role Accountabilities

• Reviewing protocol and providing inputs
• SAP & RAP preparation and Review
• Sample size calculation
• Provides statistical consultations
• Perform statistical analysis as per SAP and Protocol
• Preparing and reviewing randomization list
• Preparing and reviewing of tables listing and graphs as applicable
• Preparing and reviewing of statistical report as applicable
• Provides support for blinding and unblinding documentations
• Preparing and reviewing standard operating procedures
• Facing client to answer statistical queries
• 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: 2-3 years

1. Demonstrated Capability

Expert in SAS programming language

Clinical Trials Exposure Pharmacokinetics and Phase I-IV

1. Education

. in Statistics or Ph.D. in Statistics or any equivalent degree in Statistics

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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities