Data Management & Statistics Jobs in Life Sciences’ Post

#Hiring #Biometrics #CRO #Pharmaceuticals #Statistcian #BioStatistcian #Clinical Statistician #SAS Programming #Statistical Analyst #Clinical Trials #Clinical Services #Clinical Research

How Learning Biostatistics Empowers Research and Medical Professionals? #clincialresearch #biostatistics #statistics #medicalwriting #pharmacovigilance #analytics #sas #lifesciences #datascience #medicaladvisor #pharma #pharmaceutical #clinicaltrials #casestudy #scientificwriting #statistician #biostatistics #medicaldoctor #medicaldoctors #medicaladvisor #medicaladvice #pharma #doctors #clinicalresearch #medicalwriters #medicaladvisor #statisticians #healthcare #pharma #anova #clinicaltrials #chisquaretest #sampledistributions #msc #bsc #statistics #correlation #regresssion #parametrictest

🌟 Interested in a career as a #biostatistician? Emily Woolley, Senior Director of Biostatistics at Axio, a Cytel company, discusses her role as a leader in the #Data Monitoring Committee (DMC) domain. Emily shares her approach to building strong client relationships and mentoring team members, emphasizing the importance of personal and professional growth in the dynamic landscape of #biostatistics. Click to learn more and to apply to one of our open positions 👉 https://bit.ly/3y57cob #biotech #biotechnology #pharma #pharmaceutical #pharmaceuticalindustry #datamonitoringcommittee #data #clinicaltrials #clinicaldevelopment #statistics #Bayesian #adaptivetrials

🌟 Interested in a #career as a #Biostatistician? Brooke Smith (Purvis), Senior Biostatistician with Cytel’s FSP, shares her experience, some of the impactful #clinicaltrial projects she’s working on, and what it’s like to work at Cytel. Click to learn more: https://bit.ly/3RS96jO #statistics #biostatistics #programming #statisticalprogramming #pharma #pharmaceutical #pharmaceuticalindustry

🌟 Interested in a career as a #biostatistician? Emily Woolley, Senior Director of Biostatistics at Axio, a Cytel company, discusses her role as a leader in the #Data Monitoring Committee (DMC) domain. Emily shares her approach to building strong client relationships and mentoring team members, emphasizing the importance of personal and professional growth in the dynamic landscape of #biostatistics. Click to learn more and to apply to one of our open positions 👉 https://hubs.ly/Q02yQ-CM0 #biotech #biotechnology #pharma #pharmaceutical #pharmaceuticalindustry #datamonitoringcommittee #data #clinicaltrials #clinicaldevelopment #statistics #Bayesian #adaptivetrials

Dossier and Its Key Components: A dossier is a comprehensive document that contains all the necessary information about a drug, including its chemical composition, manufacturing process, preclinical and clinical trial data, safety and efficacy profiles, pharmacokinetics, and pharmacodynamics. It serves as the basis for regulatory authorities to evaluate the drug's safety, efficacy, and quality for approval. Dossiers vary in complexity depending on regulatory requirements but typically include detailed information to support the approval process. A dossier typically includes several key components: 1. Administrative Information: Details such as the drug's name, manufacturer information, and contact details. 2. Chemistry, Manufacturing, and Controls (CMC): Information about the drug's composition, manufacturing process, and quality control measures. 3. Nonclinical Data: Preclinical studies evaluating the drug's safety profile, including pharmacology and toxicology data. 4. Clinical Data: Results from clinical trials assessing the drug's efficacy and safety in humans, including study protocols, results, and analyses. 5. Pharmacovigilance: Information on post-market surveillance plans and safety monitoring measures. 6. Regulatory Documents: Any regulatory approvals, correspondence, or relevant regulatory submissions from other jurisdictions. 7. Labeling and Packaging: Details on the drug's labeling, packaging, and instructions for use. 8. Risk Management Plan: Strategies to identify, characterize, and minimize risks associated with the drug's use. These components collectively provide a comprehensive overview of the drug's development, testing, and regulatory status, aiding regulatory authorities in their evaluation for approval. Stay Tuned Abu Talha B. #dossier

#Clinical_Success_Odessey #Day_2 Drug Discovery, Development & Approval Drug Discovery is a process of identifying chemical entities that have the potential to become therapeutic agents to solve the unmet medical needs, Drug development is the process of bringing a new drug molecule into Clinical practice. This whole process is can be summarized in 6 steps step 1- Drug Discovery: identification and validation for new lead by Target based drug discovery and Ligand based Drug discovery step 2 - Preclinical Research: Drug undergo laboratory and animal testing (Invitro, Ex vivo & In-vivo) to study toxicity, pharmacokinetics, IC50/EC50 step 3- Clinical Research, Drugs are tested on subjects (humans) to make sure they are safe and effective step 4-FDA approval: FDA reviews all the submitted drug related clinical study reports (NDA Submission) and make a decision to approve or not to approve step 5- Scale up: Manufacturing, Bulk production to meet market demands step 6-FDA post marketing safety monitoring: FDA monitors all drug and device safety once products are available for use (Long term associated Adverse events & Effectiveness) Thanks for reading, Abhishek actively looking for fresher level opportunities in Clinical Research & CDM, Pharmacovigilance, Regulatory Affairs, Syneos Health IQVIA Research & Development Solutions Fortrea

Calling #Pharmaceuticals and #CROs 👉 Are you looking for expert #Biostatistics and programming partners for your #ClinicalTrials? Look no further than PHARMA-STATS! Our team of highly skilled and experienced biostatisticians has been providing top-notch solutions for over 20 years in more than 15 therapeutic areas, covering all phases of clinical trials. Our #Ahmedabad based office serves as the hub for delivering tailored solutions that meet your specific needs. Our commitment to excellence has earned us a reputable presence in the industry, with numerous successful collaborations and satisfied clients. #Connect with us by #email [email protected] to partner with Pharma-Stats for robust biostatistical analysis solutions. PHARMA-STATS coming ahead with a visionary mission to become the ultimate 'Single Point Statistical Solution for Pharmaceutical Drug Development and Health Intelligence.' - Dr Nirali Mehta ✨ "Together, let's drive medical advancements with data-driven precision." #biostatistics #clinicaltrials #dataanalysis #pharmastats #pharmaceuticals

Are you using "AI/ML" for Drug safety and pharmacovigilance? Does "Predictive Analytics for Risk Assessment" give you accurate results? - AI/ML models can predict potential risks associated with drugs based on historical data, patient characteristics, and other relevant factors. Predictive analytics help in proactively addressing safety concerns before they escalate. Challenge: However, what about a new active substance/INN for which there is limited historical data and scant scientific literature published? Here is what needs to be considered to program the models: - Pharmacokinetics: AI algorithms can analyze complex datasets to predict drug absorption, distribution, metabolism, and excretion (ADME) properties, aiding in the design of optimal dosage regimens. Prediction of potential drug-drug interactions by analyzing pharmacokinetic profiles, reducing the risk of adverse effects due to interaction - Pharmacodynamics: AI models facilitate the prediction of drug-receptor interactions, model disease progression, and analyze the impact of drugs on entire biological pathways. Predictive toxicology and adaptive dosing strategies, driven by AI, aid in early safety assessment and dynamic dose adjustments. - Preclinical & Early clinical data: Analyze preclinical and early clinical trial data to identify potential safety signals. Utilize and build predictive and analytical models to assess the likelihood of adverse events based on characteristics of the compound, patient population, and other relevant factors. - Development of Predictive Models: Employ machine learning algorithms to build predictive models that assess factors such as dose-response relationships, genetic variations, and patient characteristics. - Continuous Monitoring and Updating Models: Implement real-time monitoring systems that continuously update predictive models as new data becomes available. This ensures that risk assessments are based on the most recent and relevant information throughout the drug's lifecycle. #drugsafety #jobs #career #pharmacovigilance #bpharm #mpharm #MBBS #MD #BDS #BAMS #clinicaltrials #drugdevelopment #SDEA #PVAs #pharmaceuticalindustry #clinicalresearch #clinicaldevelopment #regulatoryaffairs #pharmaceuticalcompanies #pharmaindustry #biotech #medicalaffairs #pharma #biopharmaceuticals #vaccines #drugdiscovery #medicaldevice #pharmaceuticalsciences #lifesciences #signaldetection #aggregatereports #riskmanagementplan #RMP #medicine #medical #healthcare #fda #medicaldevices #training #safety #onlinetraining #ICSR #PBRER #DSUR #PSUR #PADER #REMS #opportunities #interview #AI #ML #pharmacokinetics #pharmacodynamics #drugdevelopment