Manager, Biostatistics

Sun Pharmaceutical Industries, Inc.; Gurgaon; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc. in Gurgaon is looking for an experienced Statistician. This key role involves developing statistical protocols, collaborating on clinical trials, and ensuring data integrity in compliance with regulatory standards.

The ideal candidate will have a Ph.D. or M.S. in Biostatistics or Statistics and at least 2 years of industry experience (or 5 years for M.S.). Excellent organizational and communication skills are critical for success in this role.

Qualifications

• Strong knowledge of statistical analysis principles and techniques.
• Experience with NDA/BLA and familiarity with eCTD submission is advantageous.
• Excellent verbal and written communication skills essential.

Responsibilities

• Develop statistical designs and analysis plans for clinical protocols.
• Collaborate with teams to ensure data collection aligns with project needs.
• Prepare statistical reports and presentations for project teams.

Skills

Statistical analysis

SAS

R

Phase I to IV drug development

Regulatory submission experience

Attention to detail

Teamwork

Education

Ph.D. or M.S. in Biostatistics or Statistics

Job description

Position Summary

Sun Pharma is seeking an experienced and motivated Statistician 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 science, statistical programming and other stakeholders to ensure data collection instruments and database implementation meet 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 maintain high quality.
• Project Team Involvement: Partner with clinical and regulatory teams to create development strategies for assigned projects. Represent the department on project teams to provide statistical input to compound/drug development and align with functional management. Lead communication between assigned project teams and the department to ensure timely communication of updates, proper statistical strategies, and alignment of decisions and priorities.
• 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 presentations 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 two or more direct reports.
• Regulatory Activities: Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software to meet SOPs and regulatory requirements.
• Compliance: Comply with applicable corporate and divisional policies, procedures and cultural values. Maintain up‑to‑date knowledge of SOPs and working practices relevant to managers and the statistics function. Ensure compliance with department standards, GxP and best operating practices for staff and self. Complete all assigned training on time.

Required Qualifications

• Demonstrated good understanding of Phase I to Phase IV drug development.
• Strong knowledge of the principles and techniques of statistical analysis, interpretation, and clinical relevance.
• Knowledge of statistical analysis software SAS and R.
• NDA/BLA experience with eCTD submission is a plus.
• 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 responsibilities and understands the impact of efforts, results, and attitudes on others.
• Use teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed while being capable of highly independent work when efficiency is required.
• 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 issues.

Educational Qualification

Ph.D. or M.S. in Biostatistics or Statistics.

Experience

At least 2+ years for Ph.D. (or 5+ years for M.S.) of industry experience or equivalent in a pharmaceutical R&D environment.

Disclaimer

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbents.