Lead Biostatistician

Sun Pharmaceutical Industries, Inc.; Gurgaon; Hybrid; INR 1,500,000 - 2,000,000; Full time

Job summary

A leading pharmaceutical company is looking for a Senior Manager to act as a study biostatistician. The role involves authoring statistical analysis plans, conducting statistical analyses for clinical trials, and collaborating within project teams. Candidates should have a PhD with at least 5 years of experience or a Master's with 10 years. Strong knowledge of SAS and R is essential. The position offers a hybrid work environment in Gurugram or Mumbai.

Qualifications

• Preferably PhD with at least 5 years of experience or Master with 10 years.
• Understanding of Phase I to IV drug development.
• Strong knowledge of statistical analysis principles.

Responsibilities

• Serve as study biostatistician on development programs.
• Author statistical analysis plan and oversee documentation.
• Plan and implement statistical analyses for clinical studies.

Skills

Statistical analysis

Teamwork

Verbal and written communication

Organizational skills

Problem-solving

Education

PhD

Master's degree

Tools

SAS

R

Job description

Company: Sun Pharmaceutical Industries Ltd

Title

Senior Manager

Job Grade

Senior Manager

Location

Hybrid at Gurugram or Mumbai

Key Responsibilities

At Sun Pharma, we commit to helping you “Create your own sunshine”—by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Responsibilities

• Serve as study biostatistician on development programs and multiple studies.
• Author statistical analysis plan, TFL shells and other study-related statistical documents.
• Review AdaM Specification, oversee the generation of AdaMs and TFLs and ensure timely high-quality deliverables.
• Plan and implement statistical analyses, provide statistical input to the clinical study report and perform statistical functions for submission-related activities on the assigned programs.
• Plan and execute exploratory analyses and statistical consultation within applicable cross-functional teams.
• Provide statistical support for Health Authority requests, publications, presentations and posters at medical conferences/symposia, as assigned.
• Contribute to the development and implementation of innovation in statistical methodology and trial design; perform simulations to assess various study design options and analysis approaches.
• Attend and make statistical contributions at cross‑functional study team and project team meetings.
• Participate in process improvement, SOP development, training, and enhancing statistical technical expertise.
• Maintain a positive, results‑oriented work environment, building partnerships and modeling teamwork, and communicating to the team in an open, balanced and objective manner.
• Adhere to departmental and regulatory agency procedures and standards.

Required Qualifications

• Preferably PhD with at least 5 years of experience; Master with 10 years of experience is ok.
• 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 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 their responsibilities and understands the impact of their 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 yet is 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.
• Broad experience in an emerging, publicly traded company environment is a plus.

Job Requirements

Educational Qualification and Experience: Preferably PhD with at least 5 years of experience OR Master with 10 years of experience.

Disclaimer

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to 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 incumbent(s).