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Statistics & Data Corporation (SDC)
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Principal Biostatistician

Principal Biostatistician

Statistics & Data Corporation (SDC)

8 - 10 years

10 - 14 Lacs

hyderabad

Posted:1 hour ago| Platform:

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Skills Required

cro sap diagnostics sas project management analytical pharma consulting clinical trials clinical research

Work Mode

Work from Office

Job Type

Full Time

Job Description

Serve as an internal consultant for biostatistics analysis tools and methods

Serve as a subject matter expert during client and vendor meetings for biostatistics analysis support

Actively support business development in capabilities presentations to prospective and current clients

Effectively manage assigned clinical study budgets for biostatistics analysis support

Develop, coach and mentor junior biostatistics department personnel

Act as the lead statistician on clinical research projects and help with SAS programming

Provide statistical expertise for study design of clinical trial protocols

Write statistical methods section of the study protocol, as needed

Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed

Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP)

Program summary tables, data listings and graphical representations of clinical trials data

Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data

Prepare/review key sections of clinical study reports and various regulatory documents

Perform statistical QC of all department outputs including analyses and clinical study reports

Provide statistical support to answer questions from external clients (such as FDA, Investigators)

Contribute to the development, maintenance, and training of standard operating procedures (SOPs)

Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed

Manage biostatistics timelines, budgets, and client expectations

Adhere to all aspects of the Statistics & Data Corporation s quality system

Comply with Statistics & Data Corporation s data integrity & business ethics requirements

Perform other related duties incidental to the work described herein

Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills

Effective leadership, budget forecast and implementation skills

Excellent analytical skills, with the ability to process scientific and medical data

Able to work independently and in teams

Project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills

Excellent knowledge of statistical programming

Expertise in manipulating and analyzing SAS data

Able to identify data issues, present problems, and implement solutions.

Capable of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues and clients

Excellent organizational and time management skills, with the ability to multi-task

Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)

Strong interpersonal communication and presentation skills

Able to effectively collaborate across cross-functional teams

Focus on quality at all times and in all situations

Education or Equivalent Experience

A Master s degree in biostatistics, statistics or other related, scientific field and at least eight years of relevant professional experience or a combination of education and experience.

Why SDC

We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.

We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.

We strive to provide a place of belonging to our employees with fun and engaging activities from SDC s culture club.

We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.

With a proven track record, SDC has been successfully executing client clinical programs since 2005.

Take a look at how you can join our team!

#LI-Hybrid

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Principal Biostatistician