[15h Left] Biostatistician

JOB DESCRIPTION Job Title Assistant Manager- Biostatistics Department BDM Biostatistics and SAS 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 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 Biostatistical activities in Biometrics Department for Clinical Studies Phase 1-4 Role Accountabilities Reviewing protocol SAP RAP preparation and implementation Sample size calculation Provides statistical consultations Preparing and reviewing randomization list Perform Statistical analysis as per SAP and Protocol Reviewing of SDTM and AdAM dataset 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 Training Guiding Mentoring associate biostatisticians and junior programmers Objectives setting and appraisal for the team 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 Experience 8-10 years Demonstrated Capability Expert in SAS programming language Clinical Trials Exposure - Pharmacokinetics studies and Phase I-IV studies preferably rich experience in Phase I-IV Education M Sc 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 law In addition Syngene will provide reasonable accommodations for qualified individuals with disabilities