Secunderabad, India Software 2142 Job Description Overview Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies. As a Senior Statistical Programmer , you will be responsible for programming support in the analysis and reporting of clinical trials. You will work closely with biostatisticians, data managers, and clinical teams to develop high-quality statistical programming deliverables in compliance with regulatory requirements and industry standards. Responsibilities Develop, validate, and maintain SAS and R programs for data analysis, visualization, and reporting of clinical trial data. Generate CDISC SDTM datasets, analysis datasets (ADaM), tables, listings, and figures (TLFs) for clinical trial reports and regulatory submissions. Should be able to write the SDTM specifications and ADaM specifications based on the SAP and TFL shells. Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines. Collaborate with statisticians and clinical teams to interpret and implement statistical analysis plans. Provide technical leadership and mentor junior programmers in best practices for statistical programming. Perform quality control (QC) checks on programming deliverables to ensure accuracy and consistency. Participate in the development of standard programming macros and tools to improve efficiency and reproducibility. Support regulatory submissions by preparing submission-ready datasets and documentation within Pinnacle 21. Define xml and reviewer guide experience is a plus. Qualifications Minimum 8 years of experience in statistical programming within clinical trials or pharmaceutical/biotechnology industries. Proficiency in SAS programming with experience in Advanced SAS, SAS/STAT, and SAS Macro development. Strong experience in R programming for statistical analysis and visualization. Hands-on experience with CDISC standards (SDTM, ADaM) and regulatory submission requirements. Solid understanding of clinical trial design, statistical methods, and regulatory guidelines (FDA, EMA, ICH). Experience working with clinical data from Phase I-IV studies. RWE study experience is a plus. Experience with other statistical software is a plus (Python, JMP, or other data visualization tools). Ability to work independently and collaboratively in a team environment. Strong problem-solving skills and attention to detail. Excellent verbal and written communication skills. Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
You will be playing a key role in developing clinical database products across various therapeutic areas such as Metabolic & CV, Neuroscience, Autoimmune, Oncology, and Respiratory with a focus on high quality to support Meta-analysis. Your responsibilities will include analyzing and annotating trial design information, treatments, demographics, and outcomes data from clinical literature sources. You will also be required to digitize results from graphs accurately and consistently. Collaboration will be a key aspect of your role as you work with lead consultants, peer data analysts, and quality managers to contribute to database rules, specifications, and quality processes. Additionally, you will undergo relevant training programs in areas such as Statistics, R coding, Systematic Literature review, and Data analysis methods to enhance your skills and advance within the organization. To qualify for this position, you should have a Master's degree in Pharmacology or Pharmaceutics (with relevant experience), PharmaD, Clinical Practice, Master's in Public Health, or Epidemiology. A minimum of 1-2 years of experience in Information science, Systematic Literature review, Health-economics, or public health sectors is required, with preference given to those with pharmaceutical industry experience. Strong knowledge of Pharmacology, clinical research, and clinical development processes is essential, along with familiarity with trial designs, Pharma Industry data standards, and ontologies. Having skills in statistics, data management tools like R, and a willingness to learn and collaborate in a team environment are crucial for success in this role. Excellent interpersonal skills, strong learning abilities, and a passion for supporting databases in various disease areas will be valuable assets that you bring to the team.,
Overview Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries. The Associate Director, Data Sciences, leads the development, quality assurance, and delivery of clinical trial outcome databases across therapeutic areas. This role combines strategic planning, technical expertise, project management, and stakeholder engagement to support evidence synthesis, meta-analysis, and data-driven insights. Responsibilities Database & Quality Assurance: Oversee database development, curation, QC, and deployment to platform (e.g., CODEX); ensure accurate data extraction from literature and plots; validate QC documentation and manage change impact. Technical Expertise: Conduct systematic literature reviews using PICOS, ontologies, and data standards; refine search strategies; apply clinical trial knowledge; perform R-based quality checks and exploratory analyses. Project Management: Lead planning and delivery of database products; manage resources, timelines, and change controls; ensure clear communication with clients and internal teams. Team Leadership: Mentor teams; drive process improvement, agile practices, and learning initiatives; support hiring and onboarding. Stakeholder Collaboration: Align with clients and internal teams on expectations; review project metrics and identify enhancements. Continuous Learning: Stay current with advancements in statistics, R, SLR, and data science; contribute to innovation. Qualifications Master’s or PhD in Pharmacology, Pharmaceutical Sciences, or related fields. 10+ years of experience in SLR, clinical trial databases, or health economics (6+ years for PhD holders). Strong knowledge of clinical research, trial design, PICOS, and pharma data standards. Proficiency in R; knowledge of Python and statistical methods is a plus. Key Competencies Collaboration Communication Mentorship Adaptability Client Focus Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Overview Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries. The Associate Director, Data Sciences, leads the development, quality assurance, and delivery of clinical trial outcome databases across therapeutic areas. This role combines strategic planning, technical expertise, project management, and stakeholder engagement to support evidence synthesis, meta-analysis, and data-driven insights. Responsibilities Database & Quality Assurance: Oversee database development, curation, QC, and deployment to platform (e.g., CODEX); ensure accurate data extraction from literature and plots; validate QC documentation and manage change impact. Technical Expertise: Conduct systematic literature reviews using PICOS, ontologies, and data standards; refine search strategies; apply clinical trial knowledge; perform R-based quality checks and exploratory analyses. Project Management: Lead planning and delivery of database products; manage resources, timelines, and change controls; ensure clear communication with clients and internal teams. Team Leadership: Mentor teams; drive process improvement, agile practices, and learning initiatives; support hiring and onboarding. Stakeholder Collaboration: Align with clients and internal teams on expectations; review project metrics and identify enhancements. Continuous Learning: Stay current with advancements in statistics, R, SLR, and data science; contribute to innovation. Qualifications Masters or PhD in Pharmacology, Pharmaceutical Sciences, or related fields. 10+ years of experience in SLR, clinical trial databases, or health economics (6+ years for PhD holders). Strong knowledge of clinical research, trial design, PICOS, and pharma data standards. Proficiency in R; knowledge of Python and statistical methods is a plus. Key Competencies Collaboration Communication Mentorship Adaptability Client Focus Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law. Show more Show less
As an Associate Director, Data Sciences at Certara, you will play a crucial role in leading the development, quality assurance, and delivery of clinical trial outcome databases across various therapeutic areas. Your responsibilities will include: - Overseeing database development, curation, QC, and deployment to the platform (e.g., CODEX). - Ensuring accurate data extraction from literature and plots, validating QC documentation, and managing change impact. - Conducting systematic literature reviews using PICOS, ontologies, and data standards, refining search strategies, and applying clinical trial knowledge. - Performing R-based quality checks and exploratory analyses. - Leading planning and delivery of database products, managing resources, timelines, and change controls, and ensuring clear communication with clients and internal teams. - Mentoring teams, driving process improvement, agile practices, and learning initiatives, and supporting hiring and onboarding. - Collaborating with stakeholders to align on expectations, reviewing project metrics, and identifying enhancements. - Staying current with advancements in statistics, R, SLR, and data science, and contributing to innovation. Qualifications: - Masters or PhD in Pharmacology, Pharmaceutical Sciences, or related fields. - 10+ years of experience in SLR, clinical trial databases, or health economics (6+ years for PhD holders). - Strong knowledge of clinical research, trial design, PICOS, and pharma data standards. - Proficiency in R; knowledge of Python and statistical methods is a plus. In this role, key competencies required include collaboration, communication, mentorship, adaptability, and client focus.,
Overview: Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries. We are the largest Clinical Pharmacology & Pharmacometric organization in the world, which enables us to assure that various career pathways are offered that match the ambition and personal interests of our employees! As one of Certara’s divisions, we deliver value by integrating advanced simulation approaches into the most crucial drug development deliverables - to inform internal decision-making and strengthen global regulatory submissions. Leveraging our experience in working on thousands of drug development projects on behalf of hundreds of biopharma companies, we bring a track record of success and a broad range of expertise to each assignment. Responsibilities: Play a key role in the development of clinical database products in various therapeutic areas like Metabolic & CV, Neuroscience, Autoimmune, Oncology, Respiratory etc., with a very high quality that support Meta-analysis (Pair wise, Network and Model based meta-analysis) Analyze and annotate the information pertaining to trial design, treatments, demographics and outcomes data (biomarker, clinical, safety and quality of life outcomes) for full time course from clinical literature (Journals, conference abstracts, Regulatory reviews etc.) Digitize the results from graphs for outcomes reported on linear, logarithmic and semi-log scales with precision Perform the above consistently with a very high quality Work with lead consultant, peer data analyst and Quality manager to understand and contribute to database rules, specifications and quality process Undergo relevant training programs (Statistics, R coding, Systematic literature review and Data analysis methods) and excel in these skill enhancement programs to grow in the organization ladder Qualifications: Master's in Pharmacology or Pharmaceutics (with relevant experience), PharmaD, Clinical Practice, Master's in Public Health, and Epidemiology Minimum 1-2 years of experience in the areas of Information science, Systematic Literature review, Health-economics, and public health sectors, pharmaceutical industry experience preferred Strong knowledge of Pharmacology and clinical research is a must Knowledge of clinical development and post approval phases, PICOS approach, trial designs, Pharma Industry data standards/ontologies Knowledge of statistics, data management tools like R, is an added advantage Skills & Abilities: Comfortable in a team environment and able to communicate with and collaborate with peer scientists Excellent interpersonal skills Strong learning skills to be able to support databases in multiple disease areas Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Overview Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries. We are the largest Clinical Pharmacology & Pharmacometric organization in the world, which enables us to assure that various career pathways are offered that match the ambition and personal interests of our employees! As one of Certara’s divisions, we deliver value by integrating advanced simulation approaches into the most crucial drug development deliverables - to inform internal decision-making and strengthen global regulatory submissions. Leveraging our experience in working on thousands of drug development projects on behalf of hundreds of biopharma companies, we bring a track record of success and a broad range of expertise to each assignment. Responsibilities Play a key role in the development of clinical database products in various therapeutic areas like Metabolic & CV, Neuroscience, Autoimmune, Oncology, Respiratory etc., with a very high quality that support Meta-analysis (Pair wise, Network and Model based meta-analysis) Analyze and annotate the information pertaining to trial design, treatments, demographics and outcomes data (biomarker, clinical, safety and quality of life outcomes) for full time course from clinical literature (Journals, conference abstracts, Regulatory reviews etc.) Digitize the results from graphs for outcomes reported on linear, logarithmic and semi-log scales with precision Perform the above consistently with a very high quality Work with lead consultant, peer data analyst and Quality manager to understand and contribute to database rules, specifications and quality process Undergo relevant training programs (Statistics, R coding, Systematic literature review and Data analysis methods) and excel in these skill enhancement programs to grow in the organization ladder Qualifications Master's in Pharmacology or Pharmaceutics (with relevant experience), PharmaD, Clinical Practice, Master's in Public Health, and Epidemiology Minimum 1-2 years of experience in the areas of Information science, Systematic Literature review, Health-economics, and public health sectors, pharmaceutical industry experience preferred Strong knowledge of Pharmacology and clinical research is a must Knowledge of clinical development and post approval phases, PICOS approach, trial designs, Pharma Industry data standards/ontologies Knowledge of statistics, data management tools like R, is an added advantage Skills & Abilities: Comfortable in a team environment and able to communicate with and collaborate with peer scientists Excellent interpersonal skills Strong learning skills to be able to support databases in multiple disease areas Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.