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
