Clinical Statistician

Descrizione del lavoro:

ROLE SUMMARY
The successful candidate will collaborate with study teams working effectively within the clinical triad (clinician, clinical pharmacologist, and statistician) to design studies, develop protocols, write statistical analysis plans, perform statistical analysis, write reports, present results summarizing findings, and develop publications of results. Successful candidate would also participate in regulatory submissions and response to regulatory queries. The candidate will directly contribute to Company success by increasing the strength of study designs, interpret-ability of results, regulatory strategy & interactions, biomarker strategies and by implementing methods of model informed drug development.

ROLE RESPONSIBILITIES
* Provide scientifically rigorous statistical input into project development plans, regulatory submissions and questions, interpretation of statistical results, study design, statistical analysis plans and scientific and commercialization projects.
* Be accountable for study level and submission level statistical deliverables on assigned projects, including timeliness and quality of deliverables according to project plans.
* Develop effective collaborations with others within clinical teams, partner lines (such as, Development Operations, Pharmaceutical Sciences, Safety Risk Management, Regulatory), and external regulatory, industry, professional and academic organizations.
* Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and (COMPANY NAME) standards.
* Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, modelling and simulation in support of various activities, support for publications, scientific presentations, and support to product defence.
* Participate in research on statistical methodology and its applications pertinent to the (COMPANY NAME) business needs.
* Help maintain a strong statistics community at (COMPANY NAME) through collaborations, scholarship, presentations and learnings across divisions and locations.

BASIC QUALIFICATIONS
* MSc/PhD in statistics, biostatistics, or related field with experience in pharmaceutical/healthcare or other relevant area.
* Relevant experience providing an understanding of the processes associated with clinical, regulatory and marketing operations in pharmaceutical R&D

Work Location Assignment: Flexible

Purpose
Breakthroughs that change patients' lives... At (COMPANY NAME) we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!

Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, (COMPANY NAME) is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with (COMPANY NAME) starts here!

Medical