WALK IN
-JUNIOR ANALYST – BIOSTATISTICS – 28-DEC-19
Date &
Time:
28th December from 10 AM onwards
Venue:
Indegene Pvt Ltd,
Aspen G-4 Block Manyata Embassy Business
Park,
Nagavara, Bengaluru,
Karnataka 560045
Contact Person :Sirisha
We have an exciting opportunity for JUNIOR
ANALYST - BIOSTATISTICS role who have hands on experience in R or Python for
our Bangalore office.
Location - Manyata Tech Park
Job
Description:
The Biostatistician will be responsible for
delivering statistical analytic solutions for Medical Affairs studies (MA),
Non-Interventional studies (NIS), Scientific Analytics studies and multiple
Phase I-IV clinical trials at a trial level by executing statistical analyses
plans, ensuring high quality and timely production of statistical reporting
deliverables (analysis datasets, tables, listings and graphs).
·
Responsible and accountable for the statistical activities and
support on statistical solutions for trials/publications and conferences.
Activities include providing input on statistical scientific and operational
aspects of the planning, design and reporting of trials/experiments, and
production and delivery of statistical deliverables and exploratory analyses.
·
Responsible for transcribing analysis plans into computational
solutions for the statistical programmer to implement (specifications of
derived variables, specification and development of statistical computing
solutions for inferential statistical analyses, tables and listings templates
for key reporting documents like the CSR) of Phase I-IV clinical trials.
·
Ensure that documents, specifications, programs/macros are
consistent and comply with company standards by providing input into CRF and
data structures tables, listings and figures for phase I-IV clinical trials and
submission activities.
·
Assume responsibility for reporting and analysis execution for
multiple studies. Responsibilities include, leading statistical deliverable
meetings with necessary clinical trial team members and third parties, and
exploratory analyses for ad-hoc analyses. Expected to provide support for
publications for individual clinical trials, and scientific analytical
solutions.
·
Lead study teams to ensure high quality for all assigned
deliverables and processes and ensure audit-readiness.
·
Responsible for ensuring statistical deliverables are provided to
agreed timelines.
·
Maintain and build effective relationships with internal and
external customers, utilizing support of management as needed.
·
Take lead role to collaborate with other line functions including
the clinical trial team. Explain statistical concepts in a manner easily
understood by non-statisticians, and provide adequate statistical
justifications for actions/decisions/statements, when required.
·
Provide statistical analysis solutions when exploratory analyses
are required. Implement novel methods and innovative trial designs with support
from lead statistician and/or statistical methodology as required.
·
Develop and comply with project / study standards and
specifications following internal guidelines.
·
Support quality control and quality audit of deliverables.
·
Provide input on process improvement initiatives and participate
in non-clinical project activities with support from group head.
·
Participate in non-clinical project activities as needed.
·
Provide support, coaching and mentoring to more junior
statisticians.
·
Effective participation and contributions in the Clinical Trial
Team and CDS project team.
·
Effectiveness of communication and team behaviors as assessed by
the other members of the Clinical Trial Team and CTS project team.
·
Contribution to the exploratory analyses as and when required
Experience:
·
Working knowledge of/experience with R or any other business
or research analytic software with an expertise in at least one type of
software.
·
Statistical and numerical knowledge and expertise in analytic
aspects.
·
Excellent interpersonal and communication skills.
·
Strong understanding of global clinical trial practices,
procedures, methodologies.
·
Strong understanding of regulatory requirements for design,
analysis and reporting of clinical trials
Education (minimum/desirable):
MS/ M.Sc (in Statistics or equivalent) with
3+ years relevant work experience or PhD (in Statistics or equivalent) with 1+
years of work experience
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