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Biostatistician Manager Bangalore Location

8.00 to 13.00 Years   Bangalore   17 Feb, 2020
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Dear Professionals Greetings !! Company: Leading Biopharma Company in Bangalore Department: Bio-Statistician Qualification: M.Sc, Ph.D Years of Experience: 8 to 13 Years Designation: Associate Mgr To Manger Job Description

  • Performs biostatistical and programming activities for given clinical trials involving drugs, biologics and medical devices.
  • Responsible for all statistical tasks with a high level of independence e.g. clinical trial design/planning, sample size estimations, analysis plan, defining safety, efficacy and exploratory endpoints, reporting activities including exploratory analyses and additional analyses to support publications, plus statistical consultation during the running phase Ensure timeliness and adequate quality of all deliverables for the assigned trials and project tasks.
  • Ensure timeliness and adequate quality of all deliverables for the assigned trials and project tasks. Able to manage CRO deliverables.
  • Follow processes and adhere to Health Authority requirements (SOPs, GCP and regulatory guidelines).
  • Establish and maintain sound working relationships and effective communication within the Clinical Trial Team/Global Clinical Trial Teams.
Technical/FunctionalSkills:
  1. Knowledge of applied parametric and non-parametric statistics, Mixed Model.
  2. Knowledge and experience in diabetes, immunology, oncology, MaBs, PKPD modeling, Generic Drug Development, innovative trial designs such as adaptive trials or Bayesian methods, biosimilars preferred.
  3. Be knowledgeable in drug agencies (e.g. FDA) regulations and requirements governing the conduct of drug and medical device studies including, but not limited to, GCP and ICH requirements.
  4. Knowledge and experience in pharmacokinetic studies required. WinNONLIN experience highly desirable.
  5. Experience with the following methodologies desirable: General Linear models - ANOVA, ANCOVA, t-test, F-test, etc (mixed models a plus); Non Parametric methods - Binomial test, Chi-Squared test, Wilcoxon tests; Logistic regression.
  6. Strong SAS/R programming Skills in R software specially PK PD Modelling.
  7. Good knowledge of SAS Programming/R Programming.
  8. Good Knowledge of CDM, CDISC, SDTM & ADaM programming.
  9. Past experience in diabetes, immunology, oncology, MaBs, PKPD modeling, Bayesian Statistics, innovative trial designs such as adaptive trials, group sequential and Bayesian Clinical Trials biosimilars preferred.
Interested & Eligible candidates kindly send your updated CV to sathish@bvrpc.comSalary: Not Disclosed by RecruiterIndustry: Pharma / Biotech / Clinical ResearchFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, BiotechnologyRole Category: R&DRole: Bio-StatisticianEmployment Type: Full Time, Permanent ,

Keyskills :
generallinearmodels linearmodels clinicaltrials bayesianmethods drugdevelopment commercialmodels bayesianstatistics effectivecommunication clinicaltrial cv pk sas cro cdm gcp ich sdtm adam tatementsofworksow

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