Job Title: Statistical Programmer (R) Location: Remote About the Role: We are seeking a talented Statistical Programmer with a strong background in R programming to join our dynamic team. In this role, you will collaborate with statisticians, data managers, and clinical researchers to deliver high-quality statistical programming support for clinical trials and research studies. You will be responsible for data preparation, analysis, and the generation of statistical outputs, ensuring compliance with regulatory standards. Key Responsibilities: Develop and validate statistical programs using R to support clinical trial analysis and data visualization. Create and maintain analysis datasets, summary tables, listings, and graphical presentations. Collaborate closely with statisticians to ensure accurate and efficient data analysis. Contribute to the development of statistical analysis plans (SAP) and programming specifications. Participate in data quality checks and data review processes. Ensure compliance with regulatory guidelines (e.g., CDISC, ICH, FDA) and internal quality standards. Troubleshoot and resolve programming issues related to data processing and analysis. Document programming work for transparency and reproducibility. Qualifications: Bachelor’s or Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field. 3+ years of experience in statistical & R programming within the pharmaceutical, biotechnology, or CRO industry. Proficiency in R programming, including package development and data manipulation. Strong understanding of clinical trial data and statistical methodologies. Experience with CDISC standards (SDTM, ADaM) is a plus. Show more Show less
Job Title: Statistical Programmer (R) Location: Remote About the Role: We are seeking a talented Statistical Programmer with a strong background in R programming to join our dynamic team. In this role, you will collaborate with statisticians, data managers, and clinical researchers to deliver high-quality statistical programming support for clinical trials and research studies. You will be responsible for data preparation, analysis, and the generation of statistical outputs, ensuring compliance with regulatory standards. Key Responsibilities: Develop and validate statistical programs using R to support clinical trial analysis and data visualization. Create and maintain analysis datasets, summary tables, listings, and graphical presentations. Collaborate closely with statisticians to ensure accurate and efficient data analysis. Contribute to the development of statistical analysis plans (SAP) and programming specifications. Participate in data quality checks and data review processes. Ensure compliance with regulatory guidelines (e.g., CDISC, ICH, FDA) and internal quality standards. Troubleshoot and resolve programming issues related to data processing and analysis. Document programming work for transparency and reproducibility. Qualifications: Bachelor’s or Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field. 3+ years of experience in statistical & R programming within the pharmaceutical, biotechnology, or CRO industry. Proficiency in R programming, including package development and data manipulation. Strong understanding of clinical trial data and statistical methodologies. Experience with CDISC standards (SDTM, ADaM) is a plus. Show more Show less
We are seeking a highly motivated and experienced Project Manager with a strong background in new chemical entities (NCEs), pre-formulation, and formulation development . The ideal candidate will manage cross-functional drug development projects from early discovery through clinical development, ensuring timely execution, compliance, and alignment with strategic goals. Key Responsibilities: Lead and manage projects involving NCE development , from pre-formulation through formulation and process development. Develop, monitor, and maintain project timelines, budgets, and resource allocation. Collaborate with R&D, Analytical, Regulatory, Quality, and Manufacturing teams to ensure seamless project execution. Oversee pre-formulation studies , including solubility, stability, excipient compatibility, and solid-state characterization. Guide formulation development activities for oral, injectable, or other dosage forms. Ensure compliance with cGMP, ICH, and regulatory guidelines throughout project execution. Identify potential risks, develop mitigation strategies, and proactively resolve project-related challenges. Prepare and present project updates, progress reports, and technical data to senior management and stakeholders. Serve as the primary liaison between internal teams, external partners, and CRO/CMO collaborators. Drive continuous improvement in project management processes and contribute to organizational best practices. Qualifications Master’s or Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemistry, or related field . 7+ years of experience in pharmaceutical R&D , with proven expertise in pre-formulation and formulation development . Strong understanding of drug development lifecycle , from discovery to clinical trials. Experience in managing cross-functional teams and external CRO/CMO partners. Excellent knowledge of analytical techniques , stability studies, and biopharmaceutics. Demonstrated ability to manage multiple projects, set priorities, and deliver results on time and within budget. Strong leadership, communication, and organizational skills. Familiarity with regulatory submission requirements (IND, NDA, ANDA, IMPD) is a plus. Preferred Skills Experience with oral solid dosage forms, injectables, or biologics formulation . PMP certification or formal project management training. Experience with QbD (Quality by Design) and DoE (Design of Experiments) approaches in formulation development.
Job Summary: Project Management plays a critical role in ensuring that projects are completed on time, within scope, and within budget. This position involves conducting detailed analyses of project performance, identifying areas for improvement, and developing and implementing project plans. The Project Management Analyst collaborates with cross functional teams to address project issues, perform risk assessments, and implement corrective actions. Additionally, this role involves training and mentoring junior staff. Responsibilities: Project Planning and Coordination Develop project plans and timelines Monitor and track project progress Coordinate with project team members and stakeholders Identify and resolve project issues and risks Communicate project updates and status reports to stakeholders Budget Management Develop and manage project budgets Track project expenses and ensure adherence to the budget Prepare budget reports and analysis Identify cost saving opportunities Resource Allocation Identify project resource needs Coordinate with resource managers to allocate resources Monitor resource utilization and make adjustments as needed Anticipate and address potential resource conflicts Project Documentation Create and maintain project documentation, including project charters, schedules, and status reports Ensure project documentation is accurate and up-to-date Organize and store project documents for easy access and reference Quality Control Establish quality standards for project deliverables Perform regular quality checks on project deliverables Identify and address any quality issues or concerns Risk Management Identify potential project risks and develop risk mitigation plans Monitor and track identified risks and take appropriate actions to minimize their impact Communicate potential risks to project team members and stakeholders Stakeholder Management Identify project stakeholders and their roles Communicate project updates and status reports to stakeholders Manage stakeholder expectations and address any concerns or issues Cultivate positive relationships with stakeholders to ensure project success. High Impact Behaviors: Continuous Professional Development: Professionals should be committed to lifelong learning, seeking out opportunities for self-improvement, and staying abreast of industry trends and best practices. Collaboration and Teamwork: Effective professionals understand the value of collaboration. They work well with others, contribute to team goals, and understand that diverse perspectives can lead to better solutions. Results Driven Performance: High performing professionals focus on delivering results. They set high standards for their own performance and are committed to achieving objectives efficiently and effectively. Qualifications: A bachelor’s degree in Business, Project Management, Marketing, or a related field with at least 2 years experience. Qualifications: Bachelor’s degree in Business, Project Management, Marketing, or a related field or equivalent work experience that provides exposure to fundamental theories, principles, and concepts. Strong understanding of project management principles and practices Strong analytical skills with the ability to interpret complex data. Proficiency in project management tools and software (e.g., MS Project, Asana, Trello). Excellent written and verbal communication skills. Ability to work independently and collaboratively with cross functional teams. Strong project management skills with the ability to manage multiple projects simultaneously. Knowledge of market research and competitive analysis techniques. Job Type: Permanent Pay: ₹800,000.00 - ₹1,000,000.00 per year Work Location: In person