Indegene Pvt Ltd 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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