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.,