Company DescriptionKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job DescriptionJob Description:
We are seeking a highly skilled and detail-oriented Consultant Statistician/Programmer to support Real-World Evidence (RWE) and Health Economics and Outcomes Research (HEOR) initiatives. The successful candidate will work closely with the RWE/HEOR biostatistician and will be responsible for developing, executing, and validating statistical programs using SAS and/or R to support analyses and deliverables for RWE, HEOR, and Market Access activities.
Responsibilities:Collaborate with HEOR and RWE biostatisticians to provide statistical programming support across various projects.Develop, validate, and maintain SAS and/or R programs to support statistical analyses and reporting activities for HEOR, RWE, and Market Access studies.Generate high-quality tables, listings, and figures based on clinical trial data and other relevant data sources.Perform statistical modelling and analyses as required.Utilize SDTM and Adam datasets to derive analysis datasets.Serve as the primary programmer on assigned projects, ensuring that programming deliverables are accurate and consistent.Perform quality control (QC) on statistical programs and outputs as needed.Ensure all programming activities comply with industry standards, study protocols, and statistical analysis plans (SAPs).Provide input on statistical methodologies and contribute to project deliverables.Maintain comprehensive documentation and audit trails for all programming activities.Perform rigorous data quality checks to ensure accuracy, completeness, and consistency.Requirements:Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related technical discipline.Minimum of 4 years of experience in clinical research, preferably within the pharmaceutical or CRO industry, with exposure to Phase I–IV trials.Hands-on experience with CDISC SDTM and Adam datasets.Proficiency in SAS and R programming is required.Strong analytical and problem-solving skills, with the ability to manage complex studies and meet deadlines.Experience with statistical techniques, including longitudinal data analysis, survival analysis, and statistical modelling/simulation.Familiarity with observational studies, causal inference, patient-reported outcomes (PROs), and health technology assessment (HTA).Experience with indirect treatment comparisons (ITCs), such as matching-adjusted indirect comparison (MAIC), is a plus.Prior experience in a similar role within the pharmaceutical industry, preferably with a focus on small molecule pharmaceuticals.Additional InformationAll your information will be kept confidential according to EEO guidelines.
