2 Clinical Trails Jobs

Responsibilities: Develop and validate SAS programs to transform, analyze, and report clinical trial data in accordance with SDTM and ADaM standards, study protocols, statistical analysis plans, and regulatory requirements. Generate SDTM datasets from raw clinical trial data and ensure compliance with CDISC standards and company-specific conventions. Develop ADaM datasets for statistical analysis, including efficacy and safety endpoints, and generate associated TLFs. Collaborate with biostatisticians, data managers, and other team members to ensure the accuracy and integrity of clinical trial data. Perform quality control checks on SAS datasets and outputs to identify and resolve data discrepancies or inconsistencies. Generate tables, listings, and figures (TLFs) for clinical study reports, regulatory submissions, and other project deliverables. Support ad hoc data requests and analyses from internal stakeholders, including clinical operations, medical affairs, and regulatory affairs teams. Contribute to the development and maintenance of standardized SAS macros and programming libraries to improve efficiency and consistency across projects. Stay informed about industry trends, best practices, and emerging technologies in clinical SAS programming. Key Skills: SDTM, ADaM, TLF'S, Efficacy, PK/PD, ISS/ISE Qualifications: Bachelor's degree in Computer Science, Statistics, Life Sciences, or a related field. 3-12 years of experience as a SAS programmer in the pharmaceutical, biotechnology, or contract research organization (CRO) industry. Proficiency in SAS programming, including data step, PROC SQL, PROC REPORT, and macro programming. Experience working with SDTM and ADaM datasets, as well as familiarity with regulatory guidelines (e.g., ICH-GCP).

Position : Senior Analyst Media Monitoring Education: Advanced degree in Life Sciences such as Biology or Pharmacology with relevant scientific background (e.g., MS, PharmD, Ph.D. Experience: • At least 8-10 years of relevant pharma industry or research experience, working in information sciences/ consulting, analysis, insights. Proven scientific literature search and comprehension skills with experience utilizing pharmaceutical databases and resources. Experience at a MNC or intercultural / global team environment. Experience with Windows-based computer systems (Excel, Powerpoint and so on), databases and electronic resources. Understanding of analytical tools such as Power BI or Tableau, and AI tools such as ChatGPT, Copilot will be added advantage. Strong verbal & written communication and presentation skills. Languages: Fluent spoken and written English essential. Location : Hyderabad Tenure : 6 Months CTC : 9 to 13 LPA Major accountabilities Operational delivery Knowledge of pharmaceutical industry: effective researching of scientific and non-scientific information including information on targets, drugs, competitors, experts, technologies, pipeline and business news Business news monitoring and curation experience a must besides having experience in scientific literature search Product database knowledge: OVID, Embase.com, PatBase, clinicaltrials.gov, Cortellis, Pharmaprojects, Newsedge, Factiva, etc. o Ability to effectively construct search strategies o Understanding of medical terminology, knowledge of taxonomies, thesauri o Proficient in alert strategy creation o Broader therapy area (TA) and drug mechanism understanding • Hands-on experience of working on corporate/ commercial and/ or disease-area specific scientific newsletter • Ability to perform comprehensive review of published literature and news sources to support the curation and delivery of the most relevant information Media Monitoring Specialist, Ability to connect the dots and derive meaningful insights • Analyzing and writing succinct summaries of defined scientific, medical, commercial or news content and assessing the impact Ability to comprehend and understand financials and taking into account company goals and financial standing, including extracting information from IR events, SEC filings, analyst reports etc. • Action oriented. Ability to meet deadlines and handle multiple projects simultaneously Ability to effectively correspond written and oral, with scientific/medical associates Lead productivity initiatives within service and continuously drive and monitor improvements in day-to-day work; use of technology in simplifying systems/processes Functional excellence Works in partnership with the Media Intellignece team in the NKC service to ensure deadlines are met and quality standards are upheld. This includes: • Demonstrates keen understanding of news databases with experience of utilizing news resources like NewsEdge, FirstWord, Factiva, etc. • Demonstrates understanding of literature searching and document delivery skills, resources, and tools with advanced experience with Embase, Ovid, PatBase and Clinicaltrials.gov • Deep understanding of newsletter development and curation Experience of understanding and deriving insights from financial data, financial and business news. • Time management with ability to juggle several projects and searches while meeting project deadlines • Stakeholder management, customer service excellence • Strong writing skills and verbal communication skills • Knowledge of additional languages i.e., German or Spanish or French is good to have, but not mandatory. People and organizational leadership • Be a role model for Novartis values and behaviors Foster an intercultural environment and team cohesion Key performance indicators/measures of success • Satisfaction of Media Monitoring customers with o Timeliness project initiation, alert creation o Researching skills o Team interactions o Preciseness and accuracy of alerts and curation services Effective communication skills both written and oral Best practice sharing • Execute agreed targets for self and team Media Monitoring Specialist Ensure all media monitoring service deadlines are met • Ensures team deliverables adhere to NKC agreed quality standards • All activities follow best practice and agreed processes. Highlights opportunities to improve processes and pilots new approaches Legal and ethical considerations applied in all work activities • Use of technology in simplifying systems/processes Values and Behaviors: in-line with leadership standards • Commitment to positive team environment Interested candidates share cv : busiraju.sindhu@manpower.co.in Whats app : 7013970562