Senior Manager, Biostatistics

Title Senior Manager, Biostatistics Job Grade Senior Manager Location Hybrid at Gurugram or Mumbai 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 Trial 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. Travel Estimate Not specified 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 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). Equal Employment Opportunity We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law. #J-18808-Ljbffr