Pi Health Cancer Hospitals

Company Description Pi Health Cancer Hospital is transforming India's healthcare landscape by revolutionizing cancer care through a relentless pursuit of excellence. Our vision is to bring world-class oncology to India, redefining lives and possibilities. The hospital offers high-quality compassionate care with access to innovative drugs, cutting-edge research, and renowned experts in cancer prevention, diagnosis, and treatment. We provide a comprehensive range of services, including medical, haematological, surgical, and radiation oncology, advanced diagnostic laboratory services, and state-of-the-art radiology and imaging services. Location – Hyderabad, Telangana, India (Full time) About the job The Biostatistician is responsible for the statistical analysis and interpretation of clinical trial data, working closely with cross-functional teams to ensure accurate and meaningful results. This role involves developing Statistical Analysis Plans (SAPs)and contributing to the randomization process. They will provide expert consultation on statistical methodologies and collaborate with the Statistical Programming team to ensure the integrity of data analyses and outputs. Responsibilities · Provide statistical expertise in the protocol and study design, clinical development plans, and analysis of clinical trials. · Develop and author SAPs for assigned projects, including development of well-presented mock up displays for tables, figures and listings (TFLs). · Create programming specifications for analysis datasets, TFLs etc. · Review annotated CRFs, database design and other study documentation to ensure protocol criteria are met and data is captured as required to support a high-quality database and planned interim and final analyses. Collaborate with sponsor, as needed. · Provide support for blinding and unblinding documentations. · Author the protocol statistical sections and generate SAPs and study randomization, sample size calculation, estimands, CSR outputs etc. · Collaborate closely with Programmers to review and validate data sets, tables, listings, and other statistical outputs. · Review and sign-off on relevant study documents and programming deliverables. · Provide programming support to supplemental or exploratory analyses any other internal and external ad-hoc requests. · Stay current with relevant regulatory guidelines and ensure compliance in all statistical deliverables. · Represent the biostatistics function on project teams and in cross-functional meetings such as DSMBs, DMCs etc. as needed · Perform other duties as required and assigned. Accountabilities · Demonstrate efficient and accurate completion of all responsibilities. · Support overall delivery strategy as directed by management. Education& Qualifications: · Bachelor’s degree in mathematics, statistics, data science or computing with substantial working experience in biostatistics will be considered. · Master’s or PhD in Statistics, Biostatistics, or a related field is preferred. · Proficiency in statistical programming in SAS. Knowledge of other software such as R, or Python preferred. Experience · 4+ years of biostatistics experience, in clinical trials within pharmaceuticals, biotech, or CRO. · Strong understanding of CDISC standards (e.g. SDTM, ADaM) and their application. · Experience in the life sciences, regulatory environments, and knowledge of 21 CFR Part 11 and GxP is highly preferred. Skills · Strong statistical knowledge, including experience with survival analysis, mixed models, and longitudinal data analysis. · Excellent problem-solving abilities and attention to detail. · Demonstrated ability to work independently and within cross-functional teams across time zones. · Strong written and verbal communication skills, with the ability to clearly present statistical