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Minoo Niknian

Executive Director - Statistics, Programming, Data Management, Nabi Biopharmaceuticals

Rockville, MD

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I am a Ph.D. statistician with more than 18 years of experience managing Biometrics groups in various therapeutic areas while staying hands-on in all projects’ activities. At this capacity, I plan, organize, develop, forecast, budget, and lead divisions in the biostatistics, programming, and data management fields for major international pharmaceutical companies. I have extensive experience in planning and designing experiments, designing data collection tools, statistical analyses, and reporting of phase I, II, III, IV and pharmacokinetic studies. My expertise includes but is not limited to: 
• Clinical trials (design and conduct)  
• Biostatistics 
• Data Management and Clinical Programming 
• Collaborative Consultation  
• Staff Development 
• Validation  
• Regulatory Submissions and Requirements (FDA, EMA, Health Canada) 
• SOP Development 
• Design and implementation of electronic data capture (eDC); interactive randomization and drug distribution systems (IWRS; IVRS); and electronic patient reported outcomes (ePRO). 
 
I have experience in many therapeutic areas including CV, CNS, Oncology, GI, anti-infective, Allergy, Women’s Health Care (including Osteoporosis), Dermatology, PK/PD, Vaccine, and Addiction (including smoking cessation). 
 
In addition to my core background in Statistics, my professional experience has encompassed all aspects of running clinical trials from the concept, medical development, regulatory strategy planning, protocol writing, conducting clinical trials (advising/instructing the clinical sites), data management and programming through medical writing and submission to regulatory agencies, post marketing, pricing, and due diligence activities for acquisition of new products.  
 
Furthermore, I have extensive experience in Project Management as well as managing multi-million dollar budgets, contracting CROs, negotiating budgets and timelines, and managing/directing/instructing CRO teams in the timely completion of the contracted tasks.  
 
Currently, I have been with Nabi for about 4.5 years, and I will have excellent references from the CMO (my boss) and CEO of my current employer. I am seeking new opportunities because Nabi Biopharmaceuticals is being closed. 
 
I have worked in an academic environment, large global Pharma companies, and in a small Pharma Company, Nabi. I have always made a difference in every company I have worked for. I am extremely adaptable, an excellent problem solver , and a good negotiator in all tasks from budgeting and signing contracts to reasoning with various disciplines both within the company, outside the company, and with regulatory agencies.  
 
My extensive experience as explained above along with my NDA submissions (where I reviewed statistical write ups for pre-clinical and research sections of the submission), and having been the manager of PK/PD Statistics groups gives me a nice blend of competencies to take care of any therapeutic area and all phases of Clinical Trials. 
 
I am interested in leading a therapeutic area or a group of projects, or head a Biometrics Department with or without Programming and Data Management in a hands-on manner with direct oversight

Work Experience

Head/Executive Director

Statistics, Programming, and Data Management, Nabi Biopharmaceuticals
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Rockville, MD
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November 2007 to Present

Responsible for overseeing and guiding all aspects of Clinical data acquisition, analysis, and reporting. Participate in business development, strategy planning, and design of all clinical protocols. Provide statistical advice and strategic leadership to facilitate attainment of key corporate objectives and for planning, execution, and regulatory requirement for all phases of drug development. 
 
Assist in the determination of strategic objectives for regulatory filing; assume the primary statistical role in the creation of registration documents and in interactions with regulatory agencies. 
 
Responsible for managing the resource and budget of the group and developing effective resourcing strategy. 
 
Primary statistical advisor on overseeing and guiding the analysis of a large Proof of Concept study for Smoking Cessation; design, conduct, and analyses of a follow-up study to find the best dosing schedule; design of pivotal phase III studies and other studies within the clinical development plan; major contributor in protocol development, preparing initial End of Phase 2 package for the FDA, and all the responses to follow-up data-related questions; preparing the SPA (Special Protocol Assessment) package including SAP and response to the FDA's comments on the protocol and procedures. Primary statistical contributor on preparation and presentation of data related documents at various Due Diligence meetings. 
Responsible for hiring, negotiating, and advising various CROs to ensure a seamless phase III program and submission package. Coaching and mentoring internal, CRO, and contract staff on solutions to problems across all studies and all disciplines. Major contributor in design and implementation of electronic systems - such as eDiary (ePro), electronic data capture (EDC), and IWRS (for interactive randomization and drug distribution) to help manage, automate and streamline the clinical trial processes towards speedy completion with highest data integrity and ethical standards.

Director

Biometrics, Schering AG Pharmaceutical Company
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Montville, NJ
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June 2001 to November 2007

Responsible for leading the Statistics unit in Female Health Care (FHC), providing statistical, clinical methodological, regulatory, SAS programming, and data management input for all studies. Provided input to clinical team members to conduct phase I through phase IV studies that met project objectives, FDA guidelines and clinical trial methodology standards. Ensured efficient and timely handling of clinical studies while maintaining a high level of quality. Actively participated in introducing processes to effectively and efficiently implement and accomplish corporate goals and objectives. Continuously coached and developed direct reports to enhance their growth and contribution to projects. 
 
Hands-on involvement in protocol design, in-depth reviews of protocols and statistical analysis plans, and preparing regulatory documents for all FHC projects. Key statistical contributor to all project-related discussions with the FDA for Berlex regarding US projects. Prepared all statistical documents in response to the FDA review questions. Contributed extensively in preparing several NDA submissions, several SNDAs, several pre-IND and pre-NDA packages, and phase IV commitments for an already approved drug. Actively involved in development of all clinical and regulatory strategies within FHC therapeutic group. Provided high-level consulting to key leaders of the company. 
 
During the last year of my employment with the merged company (called Bayer Health Care) served as Principal advisor to the Gynecology & Andrology Medical Development Group on (1) statistical, scientific, and regulatory issues; (2) ensuring the overall planning, organization and coordination of Medical Data Sciences support for the Gynecology & Andrology Medical Development Group in the US; (3) serving as the member of the Gynecology & Andrology Medical Affair team for all FHC products, and the member of Medical Affair Publication Strategy team for the most important FHC drug product. My duties involved extensive discussions on concepts, generation of hypotheses, evaluation of the data using adequate and accurate statistical methodology, and in-depth literature review. (4) Serving as member of the Safety Task Force responsible for tracking and evaluating all the serious adverse events related to FHC drug products.

Leader of the FHC Biometrics --Continued

Female Health Care
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2001 to 2007

Female Health Care was and still is the most important therapeutic area for the company. Most of the new drugs that were approved or had a new indication all came from FHC during my tenure as the Leader of the FHC Biometrics group in the US. From 2001 to 2006, responsible for 5 NDA submissions and 5 approvals despite more stringent FDA approval process due to controversies surrounding hormone replacement therapies. Moreover, in this capacity, led the statistical responses to on-going series of questions from the FDA (during the first quarter of 2006) on complicated issues leading to a new indication that has never been granted to this class of drug products.

Independent Consultant

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2000 to 2001

Director, Biostatistics and Data Management

Aventis Pasteur
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Swiftwater, PA
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1999 to 2000

Responsible for establishing the Division of Biostatistics, Statistical Programming, and Data Management according to the regulatory requirements; directing the statistical, programming, and data management functions of the Clinical Development; responsible for budget, resourcing, and administration, setting up agreements and budget for CROs, and providing training to all Clinical Development staffs. 
 
At this capacity I have written Biostatistics SOPs for all the activities supported by the statisticians and programmers; defined all the activities performed by data management by providing flow charts; prepared appropriate forms pertinent to each activity to document departmental activities for any regulatory audit, such as the FDA visit. Oversaw and contributed to the implementation of the Clintrial system for data management, supervised, provided input, and reviewed SOPs governing the Clintrial system in order to accomplish the IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification) of the system. Introduced remote data capturing to data management and clinical staff. Provided plan for establishing standard programming systems for all vaccine-related data, and designed tables for this standard package. 
 
Provided extensive revision to the protocol template used by the corporate globally, and in turn revised the Clinical Study Report template. Provided extensive training for standardization of CRF for various studies and instructions to the investigators to fill out the CRFs. Assisted Clinical Development staff in writing SOP for out sourcing projects and managing CROs. 
 
Designed and implemented activity-based tracking system for my department for project management and resource allocation. Introduced and implemented Statistical Analysis Plan for all active protocols. 
 
Established CSR (Clinical Study Report) tracking system, defined relative relationships, and set the timelines for various functions in order to ensure timely delivery of clinical documents to the Regulatory Department. 
 
Primary contributor to the Document Review Committee. Led extensive discussions with Regulatory, Quality Assurance, and Clinical Development to address and resolve regulatory and statistical issues regarding several clinical trials. Provided expert advices on all aspects of experimental design and statistical methodologies for Clinical Development Plans (CDP). Involved in protocol development, analysis, and reporting of all clinical studies.

Director, Biostatistics and Data Operations

Johnson And Johnson Company - Janssen Research Foundation
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Titusville, NJ
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1996 to 1999

Provided statistical leadership and direction for the biostatistics department. Contributed to the management of the department by defining goals and objectives, anticipating challenges, and 
developing the staff accordingly. 
 
Responsible for statistical design, analysis, and reporting for phases I through IV clinical trials for compounds in GI (Gastrointestinal), ID (Infectious disease), Dermatology, and Allergy. 
Developing internationally consistent protocols, case report forms, database, and analyses that 
support new drug applications in the US, Europe, and Canada. Initiated, designed, and implemented a re-engineering project for global analyses plans to expedite reporting of clinical trials and ease integration of global data. Coordinated and contributed to submissions of a few NDA and sNDA in GI, Allergy, and Anti-infective drugs. Extensive experience with FDA and international regulatory agencies regarding specific submissions, analyses, as well as implementing new standards and policies. Extensive contribution in SOP development. Global Analysis Sub team Leader for 2 GI drugs to ensure overall coordination of all activities within the analysis sub team (from data collection to report writing) between the US and our European counterpart. Acted as group leader to develop and implement collaboration process between Biostatistics and Outcomes Research departments. Member of the PRC (Protocol Review Committee) task force to review and approve all of Janssen's protocols, including phase I through IV and Outcome Research protocols. Heavily involved in the recruitment activities for Biostatistics as well as the Clinical area.

Senior Manager

Parke-Davis Pharmaceutical Research
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Ann Arbor, MI
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1995 to October 1996

Responsible for planning and managing clinical trials in the oncology program, cardiovascular, 
Clinical pharmacology, pharmacokinetics and drug metabolism (PDM), and CNS areas. 
Scheduling, setting priorities, overseeing, and reviewing the work required for the submission and approval of regulatory packages. Working closely with medical, regulatory affairs, project 
planning, marketing, and contracting groups in decision-making process in producing and evaluating the feasibility of clinical plans. Responsible for guiding/participating in direct 
interchanges between Parke-Davis and cooperative groups, such as ECOG and SWOG. Extensive 
participation in organizational efforts, (I) to create and implement Biometrics SOPs in compliance with the FDA requirements; (II) to write requirements for creating Macro library for 
statistical analyses; and (III) in recruiting evaluations. Directly contributing to several projects, 
guiding and actively supporting direct reports on various projects. Extensive involvement and knowledge of case report forms design, database specifications, data edit checks, data error 
resolution, programming requirements and process flow. Actively involved in reviewing system 
validation SOP for the programming department.

Manager

Parke-Davis Pharmaceutical Research
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Ann Arbor, MI
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1994 to 1995

Managed statistical support to Oncology, Clinical Pharmacology, Pharmacokinetics and Drug Metabolism (PDM), and cardiovascular areas. Primary statistician on a large phase III oncology study. 
Participated in design, implementation, analysis, and reporting of clinical trials and drug development projects. In particular, (I) a double-blind, randomized, phase III, multicenter study comparing an oncology compound with the controlled arm on standard oncology efficacy endpoints as well as quality-of-life and safety; (II) designing a phase II confirmatory study to determine the anti-tumor activity of an oncology compound and planning for future clinical development and registration; (III) designing a randomized three-way crossover study for an old cardiovascular drug due to manufacturing process alteration; (IV) evaluation of statistical design, methodology, and inference in double-blind, parallel-group, dose-response, formulation crossover, placebo controlled, multicenter study comparing the activity of BID and QID formulation of a cardiovascular drug, (V) analysis of a trial on reversing endothelial dysfunction in coronary arteries as assessed by serial ACH challenge. 
Responsible for statistical input for studies in collaboration with the NCI and ECOG. Extensive participation in case report forms design, database specification, monitoring, and FDA contacts regarding the ongoing phase III oncology study. 
Coordinating staffing, resourcing, administrative, recruiting, project planning, and marketing needs. Developed several standard operation procedures. Responsible for statistical input for all contract developments and reviews within the managed areas.

Senior Statistician II

Parke-Davis Pharmaceutical Research
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Ann Arbor, MI
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1990 to 1994

Developed and implemented plans for NDA projects in Oncology area, in collaboration with clinical, drug development, and regulatory colleagues. Involved in protocol design and development, preparation of plans for statistical analyses in cardiovascular and oncology areas. Responsible for preparing Inferential statistical analyses, including data preparation, quality review, and summarization/interpretation of clinical trials data for incorporation in statistical/clinical reports and regularity submissions. Oversaw/prepared the development of descriptive data displays (listing, summaries, graphics) ensuring their adequacy and accuracy for intended report purposes. Provided consultation in analyses of data in clinical, preclinical, and pharmacokinetics areas. Provided Survival Updates on 1 oncology drug to the FDA for 2 years after NDA approval. Collaborated with clinical colleagues to prepare first protocols on health economic outcomes in cardiovascular area.

Faculty Member, chief statistician

Department of Community Health, Brown University and Memorial Hospital of RI
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Providence, RI
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1987 to 1990

Primary statistician for a large community study, developing specific statistical methods for unique evaluation design for which no existing methods appropriate; determining the appropriate analysis for all aspects of the evaluation and sub-studies, developing sampling design and/or experimental design for all sub-studies. Collaborated with all investigators affiliated with Brown University on grant reviews and publications and provided statistical and programming support. Other responsibilities included extensive review and assistance in design of data collection instruments, testing validity and reliability of collected data, computer programming, database management, data processing, and statistical analysis. Responsible for hiring and training of all data management/programming/statistical personnel.

Biostatistician

Division of Epidemiology, School of Public Health, University of Minnesota
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1985 to 1987

Served as senior statistician in providing statistical support in design, analysis, consultation, and study direction on complex community study. Developed various custom made statistical packages for analysis of MHHP (Minnesota Heart Health Program) data. In addition to assistance in analyses and reporting of MHHP data, following topics were addressed as internal reports: 
 
• Effect of weighing MHHP analyses equally by individual when MHHP selection is actually equi-probable by household. 
• The response rate of heavy smokers when they are invited to attend a follow-up visit. 
• Study of the distribution of the decrease in blood cholesterol in educational cities. 
• The non-response bias in MHHP surveys. 
• The neighborhood (block) design effects of some basic variables in the Annual risk factor survey, as estimated from the first five years of MHHP data. 
• Will the significance of the city by year interaction be reduced if robust methods of city survey means used? 
• Use of bootstrap on MHHP, by P. Hannan and M. Niknian. 
• Analysis of exposure of MHHP as measured by various survey items, including the exposure questionnaire. 
• Analysis of information holding and message discrimination consisting of risk factor information, preventive measure and messages discriminated.

Education

Ph.D. in Statistics

Iowa State University -
Ames, IA

1982

M.S. in Statistics

Iowa State University -
Ames, IA

1979

B.S. in Statistics

Institute of Statistics and Informatics - Tehran, Iran

1976

Publications

Peer Reviewed Publications (partial list):

Niknian, M., McKinlay, S., Rakowski, W., Carleton, R. A comparison of perceived and objective 
CVD risk in a general population. American Journal of Public Health, 79 (12): 1653- 
1654, 1989. 
 
Nelson, D.J., Lasater, T.M., Niknian, M., Carleton, R.A. Cost effectiveness of different 
recruitment strategies for self-help smoke cessation programs. Health Education Research: Theory & Practice, 4(1):79-85, 1989. 
 
Rakowski, W., Asaaf, A.R., Lefebvre, R.C., Lasater, T.M., Niknian, M., Carleton, R.A. 
Information-seeking about health in a community sample adults: Correlates and association with other health-related practices. Health Education Quarterly, 17(4):379-393, 1990. 
 
Niknian, M., Lefebvre, R., Carleton, R.A. Are people more health conscious? A longitudinal 
study of one community. American Journal of Public Health, 81 (2):205-207, 1991. 
 
Niknian, M., Linnan, L., Lasater, T.M., Carleton, R.A. Use of population-based data to assess  
Risk factor profiles of blue and white collar workers. Journal of Occupational Medicine, 33 (1):29-36, 1991. 
 
Feldman, H.A., McKinlay, S.M., Niknian, M. Batch sampling to improve power in a community 
trial: experience from the Pawtucket Heart Health Program. Evaluation Review, 20 (3):244-274, 1996. 
 
Jeff Borenstein, Kathleen Wyrwich, Minoo Niknian, Joachim Marr, Paul Korner, Kimberly Yonkers. Determining Clinically Meaningful Benefit in the Treatment of Premenstrual Dysphoric Disorder. Obstetrics & Gynecology, 107:15-16, 2006 
J Maloney, P Dietze, D Watson, M Niknian, S Lee-Rough, C Sampson-Landers, PKorner. Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. Obstetrics & Gynecology, 112 (4): 773-781, Oct. 2008.  
J Maloney, P Dietze, D Watson, M Niknian, S Lee-Rough, C Sampson-Landers, PKorner. A randomized, double-blind, placebo-controlled trial of an oral contraceptive containing 3 mg drospirenone plus 20 µg ethinylestradiol in the treatment of acne vulgaris: lesion counts, investigator ratings, and subject self-assessment. J Drugs Dermatol., 8(9): 837-844, Sept. 2009.  
Joachim Marr, Minoo Niknian, Lee P. Shulman, Richard Lynen 
Premenstrual dysphoric disorder symptom cluster improvement by cycle with the combined oral contraceptive ethinylestradiol 20 mcg plus drospirenone 3 mg administered in a 24/4 regimen. 
Contraception 84: 81-86, 2011. 
 
Dorothy K. Hatsukami , Douglas E. Jorenby , David Gonzales , Nancy A. Rigotti , Elbert D. Glover, Cheryl A. Oncken, Donald P. Tashkin, Victor I. Reus, Roxanne C. Akhavain, Raafat E.F. Fahim, Paul D. Kessler, Minoo Niknian, Matthew W. Kalnik, Stephen I. Rennard Immunogenicity and Smoking Cessation Outcomes for a Novel Nicotine Immunotherapeutic. Clinical pharmacology & Therapeutics, 89 (3): 392-399, 2011 
 
Book Reviews: 
 
Niknian, M. Randomization and Monte Carlo Methods in Biology, by Bryan F.J. Manly. 
Technometrics, 35 (1):96-97, 1993. 
 
Niknian, M. Permutation Tests: A practical Guide to Resampling Methods for Testing Hypotheses, by Phillip Good. Technometrics, 37 (3):341-342, 1995. 
 
Professional Affiliations: 
American Statistical Association, Society for Clinical Trials, Technometrics, 
Educational Statistics, Biometrics Society, International Association of Survey Statisticians.

Additional Information

Research Grants: 
 
1980-1990 Minnesota Heart Health Program (MHHP) 
Sponsor: National Institutes of Health 
Role: Biostatistician. 
 
1980-1991 Pawtucket Heart Health Program (PHHP) 
Sponsor: National Institutes of Health 
Role: Biostatistician 
 
1990-1991 Biomedical Research Support Grant (BMRSG) 
Sponsor: Boehringer Mannheim Diagnostics] 
Role: Co-Principal Investigator 
 
1989-1990 Brockton Heart Savers Project (BHHS) 
Sponsor: National Institutes of Health  
Role: Biostatistician