thsti.res.in Recruitment 2014 : Biostatistician, Medical Director

Name of the organisation : Clinical Development Services Agency (thsti.res.in)
Name of the post : Recruitment 2014 Biostatistician, Medical Director
Reference No. : Recruitment Notice No: CDS / RN /1 / 2014
Notification : https://www.indianjobtalks.in/uploads/25350-139539190493CDS-RN-01-2014.pdf
https://thsti.in/application/jobs.php

THSTI Related Content :
Scientist, Technical Assistant Recruitment : https://www.indianjobtalks.in/25360.html
Senior Program Officer Recruitment : https://www.indianjobtalks.in/25356.html

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

1. Name of the post : BIOSTATISTICIAN
Emoluments : up to Rs. 1,00,000/- per month consolidated
Qualifications and Skills : PhD in Statistics
Skills :
i) Good oral and written communication skills in English.
ii) Demonstrated ability to work independently and in a multidisciplinary team.
iii) Collaborates closely with investigators, sponsors, and other project leadership to ensure that research project results and conclusions are presented accurately and without bias.
iv) Responsible for designing and validating analysis data sets, programs, and statistical output products (tables, listings, figures).
Experience :
i) 8-15 years’ experience in handling clinical trial & epidemiological studies
ii) 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.
iii) 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.

2 Name of the post : MEDICAL DIRECTOR
Emoluments : Upto Rs 1,50,000/- (consolidated) per month
Qualifications and Skills :
Essential: A postgraduate medical degree (e.g. MD in general medicine/ pharmacology/ community medicine or equivalent)
Desirable: An advanced degree/diploma in public health.
Skills :
i) Proven ability to foster a collaborative team environment.
ii) Supervisory skills including clinical mentoring and coaching skills.
iii) Effective organizational and interpersonal skills, communication and presentation skills required.
iv) Excellent written and oral communications skills in English.
Experience :
i) Approximately Fifteen years of hands-on experience in community based clinical trials; epidemiological and observational studies and /or R&D experience in pharmaceutical/biotechnology industry.
ii) Demonstrated sound knowledge of clinical regulatory standards and guidelines.
iii) Experience in New drug/ biologics/vaccine development from Phase I onwards
iv) Experience in preparing study related documents: Protocol, IB and CSR
v) Experience in safety reporting and management as per the applicable regulatory requirement.
vi) Experience in Pharmacovigilance.

How to Apply L
Interested candidates may send their CV along with photo copies of all relevant educational qualifications and experience certificates with a cover letter indicating their motivation for the position (150 words) along with three references to
Contact Postal Address:
Program Director,
Clinical Development Services Agency,
470, Udyog Vihar Phase III,
Gurgaon- 122 016,
Haryana, India
or email the same to cdsa_admin@thsti.res.in.

Last Date : 21st April, 2014.