SUN PHARMA
Location
Gurgaon | India
Job description
Sun Pharma is seeking an experienced and motivated Senior Statistician, Principal Statistician or Manager of Biostatistics to join our rapidly growing organization. Reporting to the Director, Biostatistics Lead, this position will be responsible for supporting the design, execution, analysis and interpretation of registration-directed clinical trials and global regulatory submissions. This person will work cross-functionally with internal departments and external resources on Biostatistics-related issues, ensure adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate, and apply technical expertise to the development of biostatistics standards and procedures.
Responsibilities Protocols: Direct development of statistical designs and analysis procedures for scientific protocols, ensuring they are scientifically sound, aligned with project strategy, meet regulatory objectives and make optimal use of the data to be collected. Ensure statistical analysis plan is methodologically sound and consistent with objectives of the protocol. Assist in developing project and functional standards of data collection and analysis, and implement these standards Database Activities: Collaborate with data sciences, statistical programming and other stakeholders to ensure data collection instruments and database implementation meets short and long-term project needs. Contribute to data monitoring plans. Develop and implement project specific data standards. Ensure accuracy and consistency of data released for statistical analysis Statistical Analyses: Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches leading to improvement in the efficiency and sensitivity of study results. Provide sufficient details to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately. Determine need for development of novel statistical methodology Reports and Publications: Ensure that study results and conclusions are scientifically sound, clearly presented, and supported by statistical analysis. Prepare oral and written reports to communicate results. Represent data and statistical sciences on project issues at management review and project team meetings. Provide in-depth statistical review for scientific reports and publications. Ensure the accuracy of the statistical component of scientific reports and publications and high quality Project team involvement: Partner with clinical and regulatory to create development strategies for assigned project. Represent department on project team(s) to provide statistical input to compound/drug development and align with functional management. Lead communication between assigned project team(s) and department to ensure timely communication of project team updates, proper statistical strategies, and alignment of decisions/priorities between the project team and functional managements Training and Supervising: Train and mentor staff on statistical methodology and operations. Participate in statistical methodology and operations. Participate in department seminars, short courses and presentation of scientific articles. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff. People managers will manage 2 or more direct report Regulatory Activities: Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Participant in discussions with regulatory agencies as needed. Validate external statistical software to meet SOPS and REGULATORY REQUIREMENT Compliance: Compliant with applicable corporate and divisional policies, procedures and cultural values. Maintain up-to-date knowledge of Standard Operating Procedures and working practices relevant to managers and the statistics function. Ensure compliance with department standards, GxP and best operating practices for staff and self. Complement all assigned training on time Required Qualification Ph.D. or M.S. in Biostatistics or Statistics At least 3+ years for PhD (or 6+ years for M.S.) for Sr. Biostatistician of industry experience or equivalent in a pharmaceutical R&D environment; or at least 5+ years for PhD (or 8+ years for M.S.) relevant experience for Manager Demonstrated good understanding of Phase I to Phase IV drug development Strong knowledge in the principles and techniques of statistical analysis, interpretation, and clinical relevance Knowledge of statistical analysis software SAS and NDA/BLA experience with eCTD submission Dermatology or oncology drug development experience is a plus Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company Attention to detail and quality are critical to success Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes Use teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work with efficiency Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company Forward thinking mindset with the ability to manage multiple projects, and identify and resolve issuesJob tags
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