Life Science : Trial Statistician : 15 LPA : Apply Now
- Leading ITES Company
- 2 - 5 years
- Pune
- 1 month ago
- Email to a friend
- Report this job
Job Description
Hi,
We are hiring for the ITES Company for the Trial Statistician Role.
Job Description
1. Develop documents e.g.
- Clinical Trial Protocol (CTP)
- Trial Statistical Analysis Plan (TSAP)
- Randomization specifications & initiate randomization scheme creation
- Participate in the development of Integrated Quality and Risk Management (IQRM) plan and MQRP
2. Support Trial Data Manager (TDM)
- Review the data management plan (DMP) and data collection specifications distributed by TDM - Support treatment assignment in SDTM
- Provide input to and review Data Review Plan (DRP) prepared by TDM
- Participate and provide input in meetings (e.g., Trial Oversight Meeting (TOM), organized by CTL; investigators meeting Create and maintain documents in BDS TMF
- Plan, handle and communicate about trial-specific statistical topics and issues e.g., Sample Size Calculation, Statistical Analysis Strategy Organize and chair Result Planning Meeting (RPM), prepare and participate in the Result Alignment Meeting (RAM)
- Support TPROG for TSAP implementation and statistical QC of programs, Finalization of QC/Validation. Participate in preparation of Clinical Trial Report (CTR)
- Handle unexpected data after final data delivery Wrap-up TOM
- Specify non-CTR specific analyses, Planned/Ad hoc data delivery during trial conduct, e.g. interim analysis Support electronic submission
- Data delivery at final trial closure, Give input to public disclosure of clinical trial results (CT.gov, EudraCT, etc.)
Key Skills:
a) Qualification: statistical background (B.Sc. & M.Sc. Statistics)
b) Should have experience in Sample size, Biostatistician, Mock shell, Sample sizing calculation, Statistical Analysis Plan(SAP), Statistics
c) Knowledge of Clinical Trial Protocol, Clinical Trial Report
To Apply WhatsApp 'Hi' @ 9151555*** and Follow the Steps Below:
a) Search : Job Code # 77
Job Classification
Industry: BPM / BPOFunctional Area / Department: Healthcare & Life SciencesRole Category: Healthcare & Life Sciences - OtherRole: Healthcare & Life Sciences - OtherEmployement Type: Full timeContact Details:
Company: Leading ITES CompanyLocation(s): Pune
Keyskills: Trial Data Manager Accenture Clinical Trials Clinical Research Fortrea Cognizant Wipro Biostatistician Statistical Analysis Plan Pfizer Mock shell Statistical Programming SDTM IQVIA Statistics Life Sciences Statistical QC Novo Nordisk Parexel PrimEra Trial Statistician
Similar positions
Job Listings
We are in open beta version of website, please let us know if any issues, at: info(at)indigojobs.in