Lead Statistician
Hyderabad, India
28d ago

Job Description

The Lead Statistician is responsible and accountable for leading and delivering statistical analytic solutions for multiple Phase I-

IV clinical trials at a trial level by executing RAPs, ensuring high quality and timely production of statistical reporting deliverables (tables, listings and graphs), supporting decision making at the CTT / Medical Team and working together with the Expert / Principal Statistician and the programmer with minimal guidance and support by a Group Lead.

Supervise CROs as required and ensure timely deliverables.

Major Accountabilities

1.Responsible and accountable for multiple studies RAP execution including the RAP meetings with the necessary CTT members, reporting activities, exploratory analyses / graphics and additional analyses to support publications for individual clinical trials plus statistical consultation during the running phase.

2.Lead statistical / numerical / analytic research by providing advice and solutions on computational aspects of the problem.

3.Maintain efficient interfaces with internal and external customers with advice from Expert / Principal Statistician and the Expert / Principal Statistical Programmer.

4.Maintain efficient interfaces with internal and external customers with support of CTS management, Expert / Principal Statistician, CROs and CPOs as needed.

5.Develop and comply with project / study standards and specifications following internal guidelines.

6.Establish and maintain efficient interfaces with internal and external customers with support of CTS management.

7.Make certain that documents and specifications 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.

8.Support quality control and quality audit of deliverables.

9.Attend CTT / GCT meetings to help facilitate decision making during design, conduct and reporting of clinical results.

10.Contribute to change initiatives.

11.Contribute to project level activities.

12.Provide input on process improvement initiatives and participate in non-clinical project activities with support from Group Leader.

Minimum requirements

MS / MSc / MStat (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 2+ years of work experience

Fluent English (verbal and written).

  • Working knowledge of / experience with SAS / R / Splus or any other business or research analytic software with an expertise in at least one software.
  • Good understanding of global clinical trial practices, procedures, methodologies.
  • Statistical and numerical knowledge and expertise in analytic aspects.
  • Deep knowledge of data architecture -Good understanding of regulatory requirements
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