Principal Statistician

2 weeks ago

Bengaluru, India Quanticate Full time

Overview:

- Provide high quality statistical support to clients, which conforms to current Quanticate and client-specific standard operating procedures (SOPs) and processes, and to applicable regulatory requirements.
- Act as a lead point of contact with clients and accountable for enhancing customer satisfaction.
- Provide project leadership of assigned projects and ensure project budgets are monitored and maintained and that issues and risks are effectively communicated within the organisation and with partners and clients.
- Contribute to business development activities to maintain and attract contracts involving statistical work components.
- Lead process improvement and knowledge sharing within and across functions.
- Provide advanced technical support in the delivery of projects across the function.
- Lead cross-function operational teams to ensure successful delivery of projects.
- Ensure high levels of customer care are provided by self and team.
- Responsible and accountable for daily and accurate completion of timesheets.
- Ensure that all direct reports are actively encouraged and reminded of the need for daily and accurate completion of timesheets and to closely monitor the completion metrics.

**Responsibilities**:

- Carry out complex statistical tasks requiring a high level of technical training and understanding, mentoring and supervising others in carrying out statistical tasks. Ensure sound technical content of deliverables from self, subordinates and the project team.
- Provide high quality statistical support to studies including design and analysis of studies, writing SAPs and selecting optimum statistical methods, statistical sections of study protocols, estimates of sample size, and statistical general consultancy including study design and conduct.
- Demonstrate independence and self-motivation on consultancy tasks requiring searching for, evaluating and implementing knowledge from various resources e.g. literature, experts, regulatory sources.
- Provide statistical consultancy to clients and internal customers.
- Ensure good communication with the client, including the project status and any issues that may affect data quality.
- Work with the client project team to liaise with regulatory authorities, including attending meetings with regulators if requested.
- Work as operational lead, ensuring tasks are appropriately delegated to members of the project team in line with the requirements of the project plan. Lead cross-function operational teams to ensure successful delivery of projects.
- Monitor the work of the project team, and coordinate project delivery on time and within budget.
- QC/peer review others work.
- Ensure all statistical work is complete to a high standard and in accordance with SOPs.
- Provide regulatory and submission support (PSUR, BB, DSMB, etc.)
- Ensure quality control of statistical output is executed thoroughly and in accordance with SOPs.
- Maintain knowledge of the relevant regulatory environment.Deliver excellent customer care.

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Key Contacts/Relationships (Internal & External)*
**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: Qualified mínimally to MSc level in Statistics or equivalent.
Have 8+ years of relevant experience within the pharmaceutical industry or medical sector.
Understand the principles and procedures of statistics.

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