Manoj Kumar Page * of *

Dr. Manoj Kumar

Cell: +91-981*******/999*******

Contact Address:

***, *** *-*****,

Uttam Nagar, New Delhi

Mail: aczhvw@r.postjobfree.com

aczhvw@r.postjobfree.com

To obtain research experience in Statistics with a concentration on Biostatistical methodology, software validation, project management, data management and Clinical Trials and social sciences related field with well-versed with regulatory guidelines. To teaching and trained in statistics and research methodology with SPSS, SAS and R to scholar. Educational Qualification:

Doctor of Philosophy (Statistics), August 2014

Agra University, Agra U.P., India

Master of Philosophy (Statistics), June 2007 Bachelor of Education (Mathematics), June 2006 Agra University, Agra U.P., India Dayalbagh educational Institute Agra, India Master of Science (Statistics); June 2005 Bachelor of Science (Mathematics); June 2003 Agra University, Agra U.P., India Dayalbagh educational Institute Agra, India Fellowships & Awards:

National Eligibility Test (UGC) for Lectureship in Population Studies in 2014 UGC Doctoral Fellowship, Dr. B. R. A. University, Agra, 2009 Professional Member:

Life Member, International Indian Statistical Association. Life Member, Indian Society of Medical Statistics. Life Member, Indian Society of Agricultural Statistics. Member, Data Safety Monitoring Board (DSMB) for Phase I study of Pharmmaz Pvt Ltd.

(2014-2015)

Member, Data Safety Monitoring Board (DSMB) for Phase I study of Pharmmaz Pvt Ltd.

(2016-2017)

Research Interest:

Biostatistics, Statistical Genetics, Statistical Issues in Clinical Research and Data Management. Research Methodology & Teaching and training for Statistical software like SAS, SPSS and R. Position Held:

Sr. Statistician at CCMG, Jamia Millia Islamia (A Central University) Biostatistician & Recourse person for research methodology and Statistical work Guest Faculty Positions Held:

Visiting Faculty, Department of Biostatistics, CREMA Delhi 2015-- Guest Faculty in DITE, Delhi Government Engineering College, New Delhi, 2016-- Manoj Kumar Page 2 of 9

Teaching PhD student (Paper Communication research method and SPSS), Jamia Millia Islamia, 2014-15

Taking Classes in CCMG Jamia Millia Islamia, January 2012- June 2012 Visiting Faculty, Department of Biostatistics, CREMA Delhi. August 2009 to December 2011--

Visiting Faculty, Clinical Research Institute, Delhi in 2010-- Work Experience:

1.

Handling independent project for protocol development, Randomization, Sample Size, SAP, Statistical Analysis and programming and Report writing. 2. Sr. Statistical at Jamia University. (January 2013- till) Reporting- Director of Centre

Provide help to Director in various research activities and projects, giving Statistical software training to Centre students, regular updating the CCMG website, handling the statistical analysis and report of project, conducting the students workshop relating to Statistical research aspects of course work in MA programme and making the Centre Reports and Teaching communication research method and giving statistical training. Teaching research methodology course for Phd. 3. Study Statistician –GlaxoSmithKline - Consumer Healthcare (Inventiv Health care) Gurgaon

(Feb, 2011 to Nov 2012) with total experience of more than three and half year in the Clinical and statistical research.

4. Worked as Visiting Faculty in CREMA Clinical Research Ltd. 5. Biostatistician –Fortis Clinical Research Ltd., Faridabad (Nov, 2009 to Feb, 2011) with total experience of more than three and half year in the Clinical and statistical research. 6. Jr. Biostatistician – Biometrics in CliniRx Research Pvt. Ltd., Gurgaon (Jan, 2008 to Sep, 2009).

7. Research Scholar Institute of Social Science, Agra University Agra (Jul, 2006 to Nov, 2007).

Therapeutic area includes:

Neuropathic pain, CNS, H1N1 (Vaccine trial), Dental Study, Consumer, Parkinson's disease, Immunogenicity, gastrointestinal, Schizophrenic Patients, vaccine Job responsibilities and achievements:

Perform the statistical analysis of BA/BE studies.

Co-coordinating with the Sponsor and the US team for statistical issues

Statistical analysis and review of phase II-III clinical trials

SAP (Statistical Analysis Plan) writing and review

Review and contribute in the preparation of protocol, CRF and CSR

Cross functional team co-ordination

Data management document review (DMP, Edit check specification etc)

Mockups TLF’s preparation and review

Promote concept of quality and implement methods to improve quality

Impart training to subordinates and new entrant in the department

Review of the Randomization schedule generation, Sample size calculation, SOPs preparation

Manoj Kumar Page 3 of 9

Development and validation of SAS code for statistical analysis

Co-ordination between Clinical Data Management and Clinical team during trial analysis

Sample size, Randomization, Report and statistical Analysis for BA/BE studies.

Time Point Designing and determining Washout period for BA/BE studies for various regulatory regions.

Work on WinNonlin version 5.0.1 for calculation of pharmacokinetic parameters for BA/BE studies

Job responsibilities and achievements at Clinirx:

Basic SAS Procedures: Dataset, Sorting, Content, Merging, Plots, Format, printto, Proc Freq, Proc Univariate, Proc means, Proc Report, Proc SQL, Proc tabulate, SAS ODS, Data extraction from OC, Macros etc.

Statistical Procedures: Proc Logistic, ANOVA, GLM, Mixed, Npar1way, Means etc.

Co-coordinating with the Sponsor and the US team for statistical issues

Statistical analysis and review of phase II-III clinical trials

SAP (Statistical Analysis Plan) writing and review

Review and contribute in the preparation of protocol, CRF and CSR

Cross functional team co-ordination

Data management document review (DMP, Edit check specification etc)

Mockups TLF’s preparation and review

Promote concept of quality and implement methods to improve quality

Impart training to subordinates and new entrant in the department

Review of the Randomization schedule generation, Sample size calculation, SOPs preparation

Development and validation of SAS code for statistical analysis

Co-ordination between Clinical Data Management and Clinical team during trial analysis 8. Research Student in Dept. Statistics Institute of Social Science, Agra (June 2006 to December, 2007)

Responsibilities:

Plan, execution, data collection & quality control of data

Data interpretation and report writing of the research work

To complete the research work through research papers and results

To compile information through research and experiments for the study

To analyze the microarray data for dissertation

Computer Skill:

Statistical Packages: SAS, SPSS, R, MATLAB, WinNonlin version 5.0.1 Database : ORACLE Clinical 4.5.0 (Basic knowledge), Access, Excel Platforms : Windows98, Windows XP, Window 2000, Window Vista. Languages : C, C++

Paper Published in Journal:

1 K. Rajak, M. Kumar, Onfω -Continuity in Fine-Topological Space, in International Journal of Science and Research (IJSR), page 896-900, Volume 5 Issues 12, December 2016. ISSN (Online): 2319-7064 Index Copernicus Value (2015): 78.96 Impact Factor

(2015): 6.391

Manoj Kumar Page 4 of 9

2 Nazia Afreen, Irshad H. Naqvi, Shobha Broor, Anwar Ahmed, Syed Naqui Kazim, Ravins Dohare, Manoj Kumar, Shama Parveen, Evolutionary Analysis of Dengue Serotype 2 Viruses Using Phylogenetic and Bayesian Methods from New Delhi, India, in PLOS Neglected Tropical Diseases, DOI:10.1371/journal.pntd.0004511, March 15, 2016 3 Chaudhary G, Diwakar K M, Role of Herbs in preventing Cancer, International research journal of pharmacy, April 15, 2014, ISSN 2230 8407. 4 Manoj Kumar, Vineeta Singh, Microarray Data Analysis of Acute LLTR using Statistical software’s in Rajsthan journal statistical association, vol.2, no.2, December, 2013 Paper Presented in Conference:

1 Poster presented on Peak Immature Platelet Fraction as a predictive Marker of Platelet recovery in Dengue Patients, AIIMS

2 Microarray Data Analysis of Acute Lymphoblastic Leukemia Treatment Response using Genowiz in 17th International Conference of International Academy of Physical Sciences on Emergining trends in physical sciences & technology, January 16-18, 2015 3 Statistical designs of microarray experiments: Reference and loop design in 32nd Annual Conference of Indian Society for Medical Statistics on Recent Advances in Statistical Methods and their applications in health Sciences, Jammu University, Jammu, November 1-3, 2014

4 Bio-Statistician in the paradigm of Global Pharmaceutical Companies & in Contract Research Organisation (CRO), National Conference on “Recent Advances in Statistical and Mathematical Sciences and their Applications (RASMSA-2014)” at ASC, Kumaun University, Nainital, October 4-6, 2014

5 Analysis of Microarray data: An Overview of Cluster Analysis, National Conference on

“Recent Advances in Statistical and Mathematical Sciences and their Applications

(RASMSA-2014)” at ASC, Kumaun University, Nainital, October 4-6, 2014 As Resource Person/Lecture delivered:

1 Delivered lecture on Statistical data Analysis using SPSS-I in Refresher course on Mathematics, Statistics & Operation Research, UGC-Human Resource Development Centre UGC-HRDC, Guru Ghasidas Vishwavidyalaya GGV Central University, Bilaspur, December 16, 2016.

2 Delivered lecture on Hypothesis Testing, ANOVA, ANCOVA, Correlation and Regression -II in Refresher course on Economics, UGC-Human Resource Development Centre UGC-HRDC, Guru Ghasidas Vishwavidyalaya GGV Central University, Bilaspur, December 16, 2016.

3 Delivered lecture on Hypothesis Testing, ANOVA, ANCOVA, Correlation and Regression -I in Refresher course on Economics, UGC-Human Resource Development Centre UGC-HRDC, Guru Ghasidas Vishwavidyalaya GGV Central University, Bilaspur, December 16, 2016.

4 Delivered lecture on Statistical data Analysis using SPSS-II in Refresher course on Economics, UGC-Human Resource Development Centre UGC-HRDC, Guru Ghasidas Vishwavidyalaya GGV Central University, Bilaspur, December 15, 2016. 5 Delivered lecture on Statistical data Analysis using SPSS-I in Refresher course on Economics, UGC-Human Resource Development Centre UGC-HRDC, Guru Ghasidas Vishwavidyalaya GGV Central University, Bilaspur, December 15, 2016. 6 Delivered lecture on field visits, survey, data entry in National Workshop on Research Methodology in Social Sciences organised by Association of Indian University (AIU) and in collaboration of Centre for Culture, Media & Governance (CCMG), JMI, New Manoj Kumar Page 5 of 9

Delhi, November 27, 2016.

7 Delivered lecture on workshop on questionnaire development in National Workshop on Research Methodology in Social Sciences organised by Association of Indian University

(AIU) and in collaboration of Centre for Culture, Media & Governance (CCMG), JMI, New Delhi, November 26, 2016.

8 Delivered lecture on Statistical Analysis using SPSS in National Workshop on Research Methodology in Social Sciences organised by Association of Indian University (AIU) and in collaboration of Centre for Culture, Media & Governance (CCMG), JMI, New Delhi, November 26, 2016.

9 Delivered lecture on Scale of measurement and Introduction to SPSS in National Workshop on Research Methodology in Social Sciences organised by Association of Indian University (AIU) and in collaboration of Centre for Culture, Media & Governance

(CCMG), JMI, New Delhi, November 24, 2016.

10 Delivered lectures on Biostatistics and Data analysis using SPSS, in TEQIP-II Sponsored Short Term Course on “Current Advances in Applied Biotechnology” at motilal nehru national institute of technology, Allahabad, October 15, 2016 11 Delivered lectures on How to analyze the data using SPSS, Scientific programme & workshop on Biostatistics, organized by Faculty of Dentistry and Centre for Culture, Media & Governance (CCMG), Jamia Millia Islamia, New Delhi, 07, September, 2016. 12 As Resource Person & Lectured delivered on Use & importance of Statistical tools, Hypothesis Testing, Scale of Measurement, Chi-Square, t-test, in workshop on Research Methodology for Scholar & Faculties, Sri Guru Naank Dev Khalsa College, University of Delhi, Delhi, 23-27th March 2016.

13 As Resource Person & Lectured delivered on Practical Session on SPSS for work on SPSS, t-test, ANOVA, Correlation, Regression in workshop on Research Methodology for Scholar & Faculties, Sri Guru Naank Dev Khalsa College, University of Delhi, Delhi, 23-27th March 2016.

14 As Resource Person & Lectured delivered on Hypothesis Testing, t-test, ANOVA in 10- days ICSSR sponsored Research Methodology Programme for Ph.D. Students in Social Sciences, Department of Economics, Central University of Kashmir, Srinagar, 14-23 March 2016.

15 As Resource Person & Lectured delivered on Practical Session on SPSS for work on SPSS, t-test, ANOVA, Correlation, and Regression in 10-days ICSSR sponsored Research Methodology Programme for Ph.D. Students in Social Sciences, Department of Economics, Central University of Kashmir, Srinagar, 14-23 March 2016. 16 Lectured Delivered on Introduction to SAS Software and Hand on training on SAS 9.3, in Clinical Research Clinimind, Noida, March 12-13, 2016. 17 Lecture delivered on Parametric and Non-Parametric Method and demonstration using the SPSS at ten days research methodology workshop, Dept. of Education, Tezpur University, 19-20 February, 2016

18 Lecture delivered on T-test, ANOVA, Introduction to SPSS Softwares at Ten Day Research Methodology Workshop (ICSSR Sponsored)for Research Scholars at IGNTU

(Central University), Amarkantak, MP, 27 January, 2016 19 Lectured delivered on Measurement issues- development of scale and preparation of Quantitative data at One week Faculty Development Programme (FDP) on Research Methods for Social Sciences (04 to 10 January 2016) Organised by Department of Business Administration, University of Lucknow, Lucknow, 04, January, 2016. 20 Lectured delivered on Hypothesis Concepts & Formulations at One week Faculty Development Programme (FDP) on Research Methods for Social Sciences (04 to 10 January 2016) Organised by Department of Business Administration, University of Manoj Kumar Page 6 of 9

Lucknow, Lucknow, 04, January, 2016.

21 Lectured delivered on Statistical Inferences- Non Parametric Test at One week Faculty Development Programme (FDP) on Research Methods for Social Sciences (04 to 10 January 2016) Organised by Department of Business Administration, University of Lucknow, Lucknow, 04, January, 2016.

22 Lectured delivered on Designing questionnaire at Research Methodology workshop on Communication Studies & Social Sciences, sponsored by Indian Council of Social Sciences Research (ICSSR) and organized by Centre for Culture, Media & Governance

(CCMG), Jamia Millia Islamia, New Delhi, 09-19, December, 2015. 23 Lectured delivered on Field Work at Research Methodology workshop on Communication Studies & Social Sciences, sponsored by Indian Council of Social Sciences Research (ICSSR) and organized by Centre for Culture, Media & Governance

(CCMG), Jamia Millia Islamia, New Delhi, 09-19, December, 2015. 24 Lectured delivered on Field Work & Data analysis at Research Methodology workshop on Communication Studies & Social Sciences, sponsored by Indian Council of Social Sciences Research (ICSSR) and organized by Centre for Culture, Media & Governance

(CCMG), Jamia Millia Islamia, New Delhi, 09-19, December, 2015. 25 Lectured delivered on Introduction to Statistical Software’s like SPSS at Research Methodology workshop on Communication Studies & Social Sciences, sponsored by Indian Council of Social Sciences Research (ICSSR) and organized by Centre for Culture, Media & Governance (CCMG), Jamia Millia Islamia, New Delhi, 09-19, December, 2015.

26 Lectured delivered on Parametric and Nonparametric methods at 4th Research methodology course on applied research techniques using SPSS in social sciences, CJNS, Jamia Millia Islamia, New Delhi, 10 December, 2014. 27 Lectured delivered on Parametric and Nonparametric methods using SPSS at 4th Research methodology course on applied research techniques using SPSS in social sciences, CJNS, Jamia Millia Islamia, New Delhi, 10 December, 2014. 28 Lectured delivered on ‘Statistician Role in Clinical Trial’ at Training Course on Orientation in medical Research Methodology and Biostatistical Method of Analysis at Institute of Cytology and Preventive Oncology,Noida from 07th - 9th July 2010 Conference/Workshop Organized:

1 Director and Coordinator of Workshop, National Workshop on Research Methodology in Social Sciences organised by Association of Indian University (AIU) and in collaboration of Centre for Culture, Media & Governance (CCMG), JMI, New Delhi, November 23-29, 2016.

2 Director and Coordinator of Workshop, Scientific programme & workshop on Biostatistics, organized by Faculty of Dentistry and Centre for Culture, Media & Governance (CCMG), Jamia Millia Islamia, New Delhi, 07, September, 2016. 3 Director and Coordinator of Workshop, Research Methodology workshop on Communication Studies & Social Sciences, sponsored by Indian Council of Social Sciences Research (ICSSR) and organized by Centre for Culture, Media & Governance

(CCMG), Jamia Millia Islamia, New Delhi, 09-19, December, 2015. 4 Organized and co-ordinated Training Programme on Communication Strategies for legal Manoj Kumar Page 7 of 9

awareness for senior government officials, in collaboration with UNDP Afganistan, at Jamia Millia Islamia University, New Delhi, 23Sep-04Oct, 2013 5 Organized and co-ordinated International Conference on Contours of Media Governance: Teaching, Disciplinarity, Methodology at Jamia Millia Islamia University, New Delhi, 25-27th February 2013

Workshop, Conference:

1 Workshop on “Research methodology and Biostatistics for Physiotherapy researcher” organized by the Centre for physiotherapy and Rehabilitation sciences, Jamia Millia Islamia,New Delhi on 2-3 Nov.2012

2 Participated in 28th Annual Conference of Indian Society for Medical Statistics on 11-13 Nov.2010

3 The Pre-conference Training Course on Health System Research at NIHFW,ICMR on 10th Nov.2010

4 Training Course on Orientation in medical Research Methodology and Biostatistical Method of Analysis at Institute of Cytology and Preventive Oncology,Noida from 07th

- 9th July 2010

5 International Symposium on India-An emerging Destination for Clinical Trials at Institute of Clinical Research,New Delhi on Jan.14th 2010 6 Workshop on “Considerations when conducting clinical trials ” by DIA at Delhi in March 2009

7 “International Conference on Statistics” Mumbai University, Mumbai India (May 2006)

8 “International Conference on Statistics and informatics in Agricultural Research” Indian Agricultural Statistic Research Institute, New Delhi, India (December 2006) Training attended

1 ‘Training on “Soft Skill training” at CiliniRx, Gurgaon, by Soft span Ltd in March 2009 2 ‘Training on “Role of Statisticians in Global Pharmaceutical companies & in CRO ” at CiliniRx, Gurgaon, in March 2009

3 ‘Training on “Statistician’s Perspective of a Clinical Protocol and Case Report Form” at CiliniRx, Gurgaon, in March 2009

4 ‘Training on “Statistical SAS Procedures” at CiliniRx, Gurgaon, in April 2009 5 Data Extraction Analysis and Reporting’ at CiliniRx, Gurgaon in May 2009 6 Workshop on “SAS Procedures” at CiliniRx, Gurgaon, in 09-12th May 2009 7 Training on “Statistical SOP” at CiliniRx, Gurgaon, in 08th May 2009 8 “Work Process” at CiliniRx, Gurgaon, in May 2009 9 Training on “Soft Skill” at CiliniRx, Gurgaon, in April 2009 10 Training held at Dept. of Statistics on “SPSS Software”, Institute of Social Science, Agra University, during 16-17th February, 2009 by SPSS South Asia, Bangalore.

11 Orientation Program on SPSS from Institute of Social Science, Agra and SPSS South Asia, Bangalore

12 Short course during 18-22 June, 2007 by Biostatistics and Research Center (BRTC), CMC, Vellore “Short Course on Statistical Analysis System(SAS)” 13 One month training in SPSS Software from Jalma Institute of Leprosy, Agra Manoj Kumar Page 8 of 9

Personal Details:

Father’s Name : Bhoodev Singh

Mother’s Name : Kamla Devi

Nationality : Indian

Date of Birth : 22th Feb, 1984

Marital Status : Single

Language Proficiency : Hindi, English

Passport : Available

References:

Prof. Vineeta Singh

Address: GF-1, Triveni Castle, 13 Old Vijay Nagar Colony, Agra-282004. Phone(Res.): 056********

Mobile: 941*******

Email: aczhvw@r.postjobfree.com

Prof. Biswajit Das

Director,

Centre for Culture, Media & Governance

Jamia MIllia Islamiaa

New Delhi

Email: aczhvw@r.postjobfree.com

Mobile: 981*******

Dr. Susheel Kumar Sarkar

Scientist

Division of Design of Experiments (DE)

Indian Agricultural Statistics Research Institute, ICAR Library Avenue, PUSA, New Delhi - 110 012, (INDIA) Mobile: 991*******

Tel.: +91 11-258*****-** (Ext. 4166), 25841254 (PBX) (Office) Email: aczhvw@r.postjobfree.com

Therapeutic area includes:

Neuropathic pain, CNS, H1N1 (Vaccine trial), Dental Study, Consumer, Parkinson's disease, Immunogenicity, gastrointestinal, Schizophrenic Patients, vaccine Statistical Task in Clinical Trial, BA/BE Studies and Medical Research:

Statistical inputs for protocol, CRF and CSR

Randomization schedule generation

Sample size calculation

SOPs preparation for DM and Statistical Activities

Co-coordinating with the Sponsor and the Medical team for statistical issues

SAP (Statistical Analysis Plan)

Statistical analysis

Report preparation

Manoj Kumar Page 9 of 9

Previous Study Work:

A Randomized, Double-Blind, Placebo-Controlled Phase I Study To Determine The Safety, Tolerability, Pharmacokinetics And xxx of xx and Multiple XXXXXXX

A Randomized, Comparative, OpenLabeled, Multi centric, Phase xxx To Evaluate And Compare The Safety, xxxxx And Immunogenicity Of Two drug xxxxxxx Healthy xxxxxx

A study to compare the gastrointestinal tolerability of Ferrochel®, xxxxxxxxx,ferrous fumarate, xxxx, ferric glycinate and Placebo

Micronutrient-supplemented milk study in women of childbearing age

Effect of Lactobacillus xx xxxx and Lactobacillus xx yyyyy on symptoms of irritable bowel syndrome: a double-blind, randomized, placebo-controlled study

Xxxxx xxx Multi-centric, Open label, Randomized, Comparative, Parallel-group, Active- Controlled Phase III Clinical Trial to Evaluate Safety and Efficacy of xxxxxxxxxxxxxxxx in Patients xxx with xxxx xxxxx xxxxxx xxxxxxxx”.

A xxx-Week, Randomized, Double-Blind, Parallel Group xxx Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses xxxxxxx Compared To xxx xxxx In xxxx Patients Previously Treated In xxxxxxxxxxx.

A Phase II, Pilot, Randomised, Placebo-Controlled, Double-Blind, Study To Determine The Safety, Tolerability And Preliminary Evidence Of Analgesic Efficacy Of xxxxxxxxxxxxxxx Dental Pain xxxxxxxx xxxxxxxx.

A Phase III, Double-Blind, Placebo-Controlled Study To Determine The Efficacy And Safety Of A xxxxx And xxxxxxxx Dose Of xxxxxxxx, As Add-On xxxxxxx, In Patients xxxxxx Parkinson's Disease xxxxx, xxxxxx A Stable Dose Of Levodopa xxxxxxxxxxxxxxxxxxxx

A phase III, double blind, placebo controlled, 24 -xxx extension study to xxxxxxxxxxxx and xxxxxxxxx, in patients with xxxxxxxxxxx with motor fluctuations, treated with a xxxxxxxxxxx

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