Senior Manager Biostatistics

Sun Pharmaceutical Industries Ltd; Gurgaon; Hybrid; INR 4,000,000 - 7,000,000; Full time

Benefits offered by this job

Sun Pharma Benefits

Job summary

Sun Pharma is seeking an experienced Senior Manager of Biostatistics to join our rapidly growing organization. You will lead the design, execution, analysis and interpretation of registration-directed clinical trials and global regulatory submissions, working cross-functionally to ensure regulatory compliance and high-quality statistical outputs.

Reporting to the Senior Director, Biostatistics Lead, you will drive statistical plans, analyses and methodological innovations across development

Qualifications

• PhD with at least 5 years of experience; Master with 10 years acceptable.
• Proficient in Bayesian methods, adaptive trial design and power calculations.
• Strong knowledge of drug development from Phase I to IV.
• Experience with SAS and R for statistical analysis.
• NDA/BLA experience with eCTD submission is a plus.
• Experience in dermatology or oncology drug development is advantageous.

Responsibilities

• Serve as study biostatistician on development programs and multiple studies.
• Author statistical analysis plans, TFLs and related documents.
• Review AdaM specifications, oversee AdaMs and TFLs for timely delivery.
• Plan and implement statistical analyses for submissions.
• Support regulatory requests, publications and conference presentations.
• Innovate in statistical methodology and trial design; run simulations.
• Participate in cross-functional study and project team meetings.
• Contribute to SOPs, training and statistical expertise growth.

Skills

Bayesian methods

Adaptive trial design

Power calculations

SAS

R

NDA/BLA experience

Dermatology/Oncology

Clinical statistics

Education

PhD

Master's degree

Tools

eCTD submission

Job description

Job Description:

Title: Senior Manager, Biostatistics

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.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.

JOB DESCRIPTION

Sun Pharma is seeking an experienced and motivated Senior Manager of Biostatistics to join our rapidly growing organization. Reporting to the Senior 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

• 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 orientated 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)
• Bayesian techniques, Adaptive Trail design and Power/sample size calculations.
• 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

Preferably PhD with at least 5 years of experience OR Master with 10 years of experience

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

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 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 incumbent(s).