Pharmacologist (PK/PD)Client liaison for any pharmacokinetic/pharmacodynamic (PK/PD), statistics or study design related issuesDevelop and review study protocolsPrepare PK/PD analysis plans and statistical analysis plansPerform parametric and non parametric PK modellingPrepare PK/PD sections of clinical study reportsAssist in preparation of clinical study reportsPrepare tables and figures for analysis resultsPrepare tables and figures of study data other than… Show more Pharmacologist (PK/PD)Client liaison for any pharmacokinetic/pharmacodynamic (PK/PD), statistics or study design related issuesDevelop and review study protocolsPrepare PK/PD analysis plans and statistical analysis plansPerform parametric and non parametric PK modellingPrepare PK/PD sections of clinical study reportsAssist in preparation of clinical study reportsPrepare tables and figures for analysis resultsPrepare tables and figures of study data other than PK/PDPerform population PK analysis, PK and PK/PD Modelling, Simulation and DDI studies.Perform compartmental and non- compartmental PK and simulation.Liaise with bio-analytical laboratories (CPR and external) regarding data transferMentor role for Clinical Project Managers and Clinical Data Coordinators for development of pharmacokinetic and statistics skillsResponsible as a Pharmacokinetic Investigator for all the clinical studies and pre-clinical studies with pharmacokinetic end-point.Actively involved in continuous improvement of the CPR’s quality systemBiostatisticianPrepare statistical analysis plansPrepare randomisation schedulesPerform statistical analyses and sample size calculation.Prepare listings, tables and figures for clinical study reportsAssist with preparation and review of clinical study reportsProvide statistical advice on study designBusiness Development SupportSupport the Senior Director Clinical Services in provision of quotations to clientsParticipate in client meetings and audits Show less

Logistic as well as technical support of Statistical Analysis, Pharmacokinetic and Programming support in clinical studies at any stage.Generating Randomization and Sample Size Calculation using Statistical method. Write Statistical methodology sections of protocols & Statistical Analysis Plans (SAP) to be carried out in the analysis of clinical studies. Perform statistical analyses of data and pharmacokinetic interpret results to ensure validity of conclusions. Create and review tables… Show more Logistic as well as technical support of Statistical Analysis, Pharmacokinetic and Programming support in clinical studies at any stage.Generating Randomization and Sample Size Calculation using Statistical method. Write Statistical methodology sections of protocols & Statistical Analysis Plans (SAP) to be carried out in the analysis of clinical studies. Perform statistical analyses of data and pharmacokinetic interpret results to ensure validity of conclusions. Create and review tables and listings; ensure internal consistency within and among tables and listings; ensure that all CRF fields are displayed on listings (as per requirement). Review clinical data for outliers, invalid and illogical data points. Modify existing macros; write new macros as well macro library. Create SAS® programs to generate or validate Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standards datasets as per the study specifications including define.xml. Develop and validate standard / ad-hoc SAS macros.Interact with data management personnel as necessary to ensure that datasets are in usable format; perform statistical diagnostics prior to database locking. Interact with medical writers in production of statistical and integrated clinical/statistical reports and other documents containing statistical information. Review draft documents. Interact with other departments, such as Clinical Operations and Project Management, to ensure a high level of client satisfaction through successful execution of projects.To provide technical support and valid scientific justification to resolve the QA, Sponsor & Regulatory queries.Meet sponsor as requested throughout trial to discuss progress of clinical studies. Allocate team resources to client projects to ensure timely delivery of activities Monitor individual workloads within the team Co-ordination with internal team and sponsors to execute technical matters. Show less