Senior Executive - Statistical Programming Job in Syngene International

JOB DESCRIPTION

Designation:Senior Executive - Statistical Programming

Job Location: Bangalore

Department: Clinical Data Management & Biostatistics

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job Purpose: To work on regulatory (CDISC) requirement and development of SAS codes in line with GCP requirement.

Key Responsibilities:

• Writing SAS program for developing the datasets (SDTM/ADaM) from raw data.
• Preparation of SAS datasets, Tables, Listings, Reports, Output Delivery system (ODS) and Summaries according to requirements
• SAP and aCRF review
• Participate in project meetings
• Prepare documentation on above production programming and validation activities
• Writing SDTM and ADaM Specification as per Protocol
• Attending Sponsor meeting and replying regulatory queries
• Closing all the Corrective actions & Preventive actions within targeted timeline and attending Audit/inspection
• Creating and updating functional Standard Operating procedures.
• Support Non-Clinical/ Quality related projects as needed
• Any other responsibilities assigned by the organization from time to time
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
• Attend training on environment, health, and safety (EHS) measures imparted company.

Educational Qualification: MCA

Technical/functional Skills:

• Advanced Certified SAS Programming
• SDTM and ADaM Specification
• Clinical Trial Exposure (Phase I to Phase IV)

Experience: 3-6 Years

Behavioral Skills:

• Communication: Having right communication is vital in connecting with internal and external stakeholders
• Self-Learning: Must be opened to learn new skills and be challenged to find solutions
• Team Player Attitude is must
• Openness to received feedback from internal and external stakeholders
• Must be adopted to the cultural changes

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.