Associate Director, Biostatistic

Company: Sun Pharmaceutical Industries, Inc.
Location: Princeton
Posted on: November 1, 2024

Job Description:

The CompanySun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US$ 5.1 billion. We provide high-quality, affordable medicines trusted by customers and patients in over 100 countries. From humble - beginnings in 1983, Sun Pharma has grown to become one of the largest generic pharmaceutical companies worldwide. We are the largest pharmaceutical company in India.In the US, we are among the top 10 generic pharmaceutical companies and are ranked second by prescriptions in the generic dermatology market. We are the largest Indian company in emerging markets with a presence in over 80 markets. Brazil, Mexico, Russia, Romania and South Africa are some of our key emerging markets. We are present across all major markets in Western Europe, Canada, Australia, New Zealand, Japan and China among others. Our presence in emerging markets and the developing world enables our teams to cross-sell and build brands with ease.Sun Pharma's global presence is supported by more than 40 manufacturing facilities spread across 5 continents, R&D centers across the globe and a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising around 2,000 scientists and R&D investments of over 7-8% of annual revenues. As a key growth driver for the company, Sun Pharma is strengthening its specialty pipeline by developing innovative medicines that help meet unmet medical needs in the areas of dermatology, ophthalmology and derma-oncology. -ProductsOur core strength lies in our ability to excel in developing generics and technologically complex products backed by our dedicated teams in formulations, process chemistry, and analytical development. We manufacture and market a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies. It includes generics, branded generics, specialty, complex or difficult to make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs) and Intermediates. Our broad portfolio of more than 2000 high quality molecules covers multiple dosage forms, including tablets, capsules, injectables, inhalers, ointments, creams, and liquids.Every year, we sell over 30 billion doses covering neuro-psychiatry, cardiology, gastroenterology, anti-infectives, diabetology, oncology, ophthalmology, dermatology, urology, nephrology and respiratory among others. Our capabilities extend beyond the development of differentiated products, including liposomal products, inhalers, lyophilized injections, nasal sprays, and controlled release dosage forms. -Position SummarySun Pharma is seeking an experienced and motivated Senior Principal Statistician or Associate Director 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
• Ph.D. or M.S. in Biostatistics or Statistics.
• At least 8+ years for PhD (or 10+ years for M.S.) for Associate Director.
• 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. -Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. -Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time. - -The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. -If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors. -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 the incumbent(s). -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. -

Keywords: Sun Pharmaceutical Industries, Inc., Fairfield , Associate Director, Biostatistic, Executive , Princeton, Connecticut