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Principal Biostatistician

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

Key AccountabilitiesProvide broad statistical support, including trial design, protocol and CRF development on specific studiesCoordinate and lead a project team to successful completion of a project within given timelines and budget.Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents.Perform sample- calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols.Review publications and clinical study reports.Interact with clients as key contact with regard to statistical and contractual issues.Perform review of derived datasets, tables, figures and data listings.Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans.Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review.Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis.Understand, apply and provide training in extremely advanced and sometimes novel statistical methods.Contribute to the development and delivery of internal and external statistical training seminars and courses.Review position papers based on current good statistical practice.Interact with clients and regulatory authorities.Biostatistician role in Parexel.Well established global Early Phase Biostatistics department .As a CRO we can provide you with a challenging and varied role as we work across following-Almost all kinds of Phase 1 trials in clinical development, and.Phase 2 Proof of Concept studiesin a wide range of therapy areasOpportunity to work as lead biostatistician on studies, and play a key role as main point of contact with our global clients.Statisticians can work office based from any of our India offices (Hyderabad/Bangalore).Statisticians who have strong experience within Early Phase are desirable but not essential.In this role, Statisticians will provide all kind of inputs on end to end activities of Biostatistics.They will give inputs to sample and protocol for specific studies, write SAPs, analyze and summarize the results of clinical studies,and coordinate with various functional leads, project managers and clientsQualificationsSkillsGood analytical skillsGood project management skillsProfessional attitudeAttention to detailThorough understanding of statistical issues in clinical trialsAbility to clearly describe advanced statistical techniques and interpret resultsFamiliarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)Prior experience with SAS programming requiredAbility to work independentlyGood mentoring/leadership skillsGood business awareness/ business development skills.Ability to work on multiple projects, plan, organize and prioritize activities.EducationPhD in Statistics or related discipline is preferredMS in Statistics or related disciplineLanguage SkillsCompetent in written and oral EnglishMinimum Work ExperienceMS in Statistics or related discipline entry level, relevant work experience in statistical analysis of 8+ years required, including minimum of 5 years as study statisticianPhD in Statistics or related discipline is preferredExperience in Early Phase studies with good pharmacokinetic knowledgeKnowledge of ADaM standards
Degree: MD/ MS (Medicine) | Ph.D. (Doctorate)

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 8-13


Bio-Statistician | Bio-Technology Research | Lecturing/teaching
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