Principal Statistician

Overview:Quanticate is the world leading data-focussed CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical input. We need talented individuals to help us fulfil our customers’ needs.

Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical programme, to small biotechs that are taking their first steps in clinical development

We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want - developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.

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Location:* Bangalore/ Hyderabad (Office Based/Hybrid)

**Responsibilities**:

- Carry out statistical tasks requiring a high level of technical training and understanding and ensure sound technical content of deliverables.
- Provide high quality statistical support to studies including coordinating the production of tables, figures and listings, writing SAPs and selecting appropriate statistical methods, statistical sections of study protocols, estimates of sample size and general consultancy.
- Carry out the core project management duties for a team of people working on a range of project management activity to include multiple complex projects. Manage workload, often working across multiple studies and managing competing priorities.
- Provide statistical consultancy verbally to clients and internal customers.
- Complete work on time. Often work to timelines assigned external to Statistics.
- Working to clients' expectations and maintaining high customer care values. Handling challenging clients diplomatically.
- Work as operational lead on medium to large scale projects, ensuring tasks are appropriately delegated to other statisticians. Support statisticians working on assigned projects and ensure they work according to SOPs.
- Ensure that the scope of projects is understood by the project team, and coordinate project delivery on time and within budget.
- Manage the scope of projects, including identification of work that is beyond scope or budget.
- Request and assign resource to ensure project delivery according to project timelines.
- Provide verbal statistical explanations to clients and internal customers.
- Ensure all statistical work is complete to a high standard and in accordance with SOPs.
- Ensure quality control of statistical output is executed thoroughly and in accordance with SOPs.
- Maintain knowledge of the relevant regulatory environment.
- Maintain good communication with the client, including the status of any assigned work and any issues including study design and conduct, and data quality.
- Engage in knowledge share activities and mentoring of other statisticians.

**Key Contacts/Relationships (Internal & External)**

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Internal*

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Work closely with their line manager to review objectives, progress and development.
- Work closely with Senior and Principal Project Delivery Managers, Portfolio Managers/Director/VP, the Senior VP of Portfolio Delivery and Head of Programming and Statistics PMO allocated project teams, Senior Programming and Statistics staff, Group Managers, Clinicians and Medical Writers for the successful delivery of statistical activities.
- Work in Partnership with support functions including HR, Finance, IT and BD.
- Lead Statisticians, Senior Statisticians and Programmers assigned to projects to coordinate successful delivery of the required deliverables.
- Provide statistical advice and support to other members of the Statistics department, company and clients.
- Work with the relevant teams, including Project Delivery Managers, Head of Functions, Lead Statisticians to discuss best use of resource, project status, etc.
- Line management of assigned personnel (as required).

**External**

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Interact extensively with clients (including client PoC, statisticians, clinicians, medical writers, project managers) to lead the client relationship and successfully deliver statistical output, ensuring excellent customer care.
- Represent the company at external conferences and forums

Qualifications**:Skills & Qualifications**

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Qualified mínimally to MSc level in statistics or equivalent
- 6-10 years of relevant experience within the pharmaceutical or medical sector
- Significant experience in two study phases, with good understanding of all phases. Breadth of therapeutic area experience.
- Understand the principles and procedures of statistics
- Good PC skills including working knowledge of Microsoft Office
- Experience using SAS or R
- Good written and oral communication skills
- Good organisational skills
- Good analytical and problem-solving skills

At Quanticate, our people are our focus, as we understand that they are the key to our success. We strongly believe in work-life balan