- Bangalore, India
Site Name: India - Karnataka - Bengaluru, India - Maharashtra - Worli Mumbai
Posted Date: Aug 12 2020
Position : Lead Statistician
Location: Mumbai / Bangalore
Reporting: Head - Clinical Matrix Team
Provide biostatistics expertise in the clinical development strategy and plan, and to conduct high quality statistical analysis in the clinical trials in a timely manner to get approvals on schedule.
Key Responsibilities :
Provide statistical inputs into the statistical part of clinical study report - BA/BE studies, Phase IV studies
- Provides statistical contributions to protocol and authors/reviews RAP with ability to actively participate in study/project team meetings
Play a key role as a Statistician Subject Matter Expert (SME) to facilitate selection and management of Contract Research Organization (CRO)/Strategic partners/External vendors as a part of outsourcing resources for biostatistics activities.
- Review the study concepts provided by strategic partners/external vendors and evaluate their scientific merits.
- Work closely with the clinical matrix team (GSK) for alignment.
- Participate bidding meetings with strategic partners/external vendors to facilitate selection of external partner.
- Be a partner within the Clinical Matrix team to oversee statistical activities related to the protocol as a subject matter expert (SME).
- At the protocol development stage: Provide high level review support, inputs into right designs, sample size or performing sensitivity analyses, reviewing regulatory documents and ensuring the study has been conducted by the local regulatory guidelines and GSK standards. Collaboratively work with CROs to address the PRF (protocol review forum) comments, working offline with the stats representatives of PRF.
- Reporting and Analysis Plan (RAP) development stage and reporting: Collaborate with strategic partners to develop RAP and ensure that they fulfil their responsibility per agreed timelines, GSK SOPs and local standards. Provide high level review support and suggestions
- CSR review and submission package preparation: Collaborate with strategic partners to develop the Clinical Study Report. Review CSR to ensure the correct messaging in line with the local regulatory submission & objectives as subject matter expert.
Provide biostatistics expertise for all projects as an SME, thus all subject matter activities are covered adequately & complied to end to end i.e. before, during and after study completion including CSR completion.
Regularly informs supervisor/manager and matrix leaders of progress with activities; escalates issues as appropriate
Lead preparation and reviewing statistical part of Regulatory submission dossier
Provide answers to statistics related inquiries from the regulatory body as appropriate.
Lead and drive process improvements
Develop, improve and strengthen statistical programming and reporting expertise.
. Educational Background Minimum : MSc in Statistics and/or a combination of education and experience; Has theoretical and practical knowledge. Minimum of 5 years experiences in biostatistics
Minimum Level of Job-Related Experience required :
Able to Optimize study design in the clinical trials;
Estimate sample size in the clinical trials
Developing Reporting and Analysis Plan (RAP) and execute statistical analysis in the clinical trials
Evaluate study results from statistical point of view
Deep and broad knowledge and skills in biostatistics; SAS programming/R-programming
Good knowledge on clinical trials;
Overall knowledge on drug development
Good communication skills
Other Job-Related Skills/Background
Deep knowledge on regulatory requirements
Technical Expertise, Scientific Leadership and Strategy-
- Solid understanding of design of experiments and application of advanced methodologies (e.g. Bayesian Methodologies, Futility and Predictive Inference, Estimands and Missing Data etc)
- Applies more complex design and analysis
- Demonstrates strong knowledge of GSK and industry standards
- Study lead statistician (global) role independently
- Shares learnings with peers and contributes at internal technical discussions/forums
- Provides statistical contributions to protocol and authors RAP with ability to actively participate in study/project team meetings
- Ability to lead / drive departmental initiatives (with Supervision)
Innovation, Problem Solving and Decision Making
- Anticipates, interprets and provides solutions to problems (including more complex problems) in processes/results and communicates them to supervisor/manager
Compliance, Quality and Governance
- Applies, guides and ensures others on team are implementing standard processes, ensuring deliverables are accurate high quality and to agreed timelines
- Strong knowledge of Good Practice (GxP), International Council for Harmonisation (ICH) requirements, internal processes and external regulations that govern drug development (where applicable)Communication and Influence
- Demonstrate effectiveness in both oral and written communications, able to express ideas and incorporate feedback
- Ability to deliver clear presentations at internal forums and/or external professional industry meetings.
Collaboration and Matrix-Working :
- Works with multi-disciplinary teams
- Represents function and/or GSK as part of a team at external organisations.
- Assists with technical training for non-statisticians or other colleagues .
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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