CDSA Gurgaon BIOSTATISTICIAN Opening

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CLINICAL DEVELOPMENT SERVICES AGENCY

An extra mural unit of Translational Health Science & Technology Institute

Department of Biotechnology, Ministry of Science & Technology, Govt. of India

470 Udyog Vihar, Phase III, Gurgaon 122016

Clinical Development Services Agency (CDSA) mission is to create, develop, and nurture world-class clinical product development capacity in India.

CDSA invites applications from high performing professionals with a desire to serve public health needs of the country for the following positions:

BIOSTATISTICIAN

Name of the post             :          BIOSTATISTICIAN

Emoluments                    :           (up to Rs. 1,00,000/- per month consolidated)

Qualifications                 :           PhD in Statistics

Skills :

Good oral and written communication skills in English.

Demonstrated ability to work independently and in a multidisciplinary team.

Collaborates closely with investigators, sponsors, and other project leadership to ensure that research project results and conclusions are presented accurately and without bias.

Responsible for designing and validating analysis data sets, programs, and statistical output products (tables, listings, figures).

Experience :

8-15 years’ experience in handling clinical trial & epidemiological studies.

Experience in using SAS software, especially base, statistics, and graphics; developing statistical analysis plans and statistical methods for protocols; demonstrated use of sample size estimation and power calculation tools/software.

Knowledge of clinical data management system (paper based and electronic data capturing) is desirable.

Coding of data on adverse events and concomitant medication using MedRA an additional plus.

Job profile :

The position will work on the design and conduct of clinical studies; the evaluation, interpretation, and reporting of study results; and regulatory submissions.

Responsibilities :

Manages research project responsibilities on statistics independently. Handles multiple competing projects and deadlines, and coordinates all the statistical needs of each research project.

Performs intermediate and advanced statistical analysis and programming for research projects.

Documents analyses, creates summaries, and presents results in written and verbal form to requestors. Writes statistical text for study reports and clinical publications. Prepares methods sections and analysis plans for incorporation in abstracts, manuscripts, and grants.

Writes own SAS code, find errors, correct, and validate output and results. Performs complex programming efficiently.

Programs analysis datasets using SAS and/or reviews those programmed by others to ensure quality products; combines multiple disparate raw databases and derives analysis variables accurately. Considers alternative programming approaches to improve quality and/or efficiency.

Experience with data management systems and collection of data following ICH guidelines.

GENERAL TERMS & CONDITIONS:

All educational professional and technical qualification should be from a recognized Board/ University and full-time.

The experience requirement specified should be experience acquired after obtaining the minimum educational qualifications required for the post.

Persons working in Govt. or Public Sector undertaking should produce “No Objection Certificate” at the time of Interview.

The qualification, experience and other requirements for the post can be relaxed at the discretion of the controlling authority, in case candidates are otherwise well qualified.

Interested candidates may please send their current CV with a recent photo and cover letter indicating their motivation for the position applied for (150 words) and three references along with the attached datasheet and excel sheet posted in the website. E-mail should be submitted with subject line “Application for the post of_________” to cdsa_admin@thsti.res.in Applications will be accepted up to December 16, 2013. This will not apply for the walk-in-interview position.

In case a large number of applications are received for each post, screening will be done to limit the number of candidates to those possessing higher/relevant qualification. Only shortlisted candidates will be contacted for further discussion.

All positions are contractual and will be guided by the provisions of contract career path http://www.cdsaindia.in/cdsa-contract-career-path developed by CDSA for its employees. Please review the contract career path before applying for any of the positions.

The salary is a consolidated sum without any other benefits. Salaries mentioned against each position are indicative and actual salary will be based on experience, qualifications, skill set, etc. of the candidates.

Position at Serial No. 3 is strictly project-based

Number of positions filled will be as per the need and availability of suitable candidates.

Incomplete applications will stand summarily rejected without assigning any reasons.

Canvassing in any form will be a disqualification.

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