Lead Biostatistics and Clinical Data Management

JOB DESCRIPTION

Job Title: Lead Biostatistics and Clinical Data Management

Job Location: 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
• 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
• Responsible for the quality of data that is being collected and processed.
• Preparing and reviewing standard operating procedures.
• Initiates the process of data quality review. Delegates CDM personnel to act as a data manager/ data quality reviewer for the specific study.

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

• 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.

Experience: 10-20 Years

Skills and Capabilities

• Expert in any programming language (preferably R and SAS)
• Clinical Trials Exposure – Pharmacokinetics and Phase I-IV

Behavioral Skills: Proficient in English (reading and writing), Stress Management, Empathy, Conflict resolution and Patience.

Education: M.Sc. in Statistics, 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 law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.