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Job Listings 2008

September

Associate and Director of Statistics and SAS Programming at inVentiv Clinical

A PDF version of the poster can be found here.

Company: inVentiv Clinical www.inventivclinical.com stock symbol: VTIV
Title: Associate and Director of Statistics and SAS Programming
Duration: Permanent
Location: Indianapolis, IN

JOB SUMMARY

The Director of Statistics and SAS Programming is responsible for oversight, leadership and direction of all statistical and SAS programming activities.
The Director of Statistics and SAS programming oversees work performed by the respective Managers of Statistics and SAS Programming to ensure compliance to FDA and ICH regulations and guidelines.
He/she is also responsible for staff retention, team performance, milestone, and deliverable compliance, training compliance, customer satisfaction, and adherence.

DUTIES AND RESPONSIBILITIES

Has management responsibility for a group of biostaticians and statistical programmers in one or more therapeutic areas, including setting employee goals and doing performance reviews
Responsible for the statistical input provided by the group to all major documents, including clinical development plans, protocols, statistical analysis plans, clinical study reports, and summaries of clinical safety and efficacy.
Provides review and guidance on statistical aspects of all FDA interactions, including FDA meetings, responses to FDA questions, and Advisory Committee meetings.
Works closely with management to ensure a coordinated approach to statistical work. Maintains comprehensive knowledge of theoretical and applied statistics and regulatory guidelines regarding clinical trial analysis and reporting. Applies new statistical procedures as appropriate.
Responsible for all on- and off-boarding activities for the statistics staff.

EDUCATION, TRAINING AND PRIOR EXPERIENCE REQUIREMENTS

Ph.D is a MUST with at least 4 years experience.
Comprehensive understanding of theoretical and applied statistics; extensive experience in clinical trials. Comprehensive understanding of regulatory guidelines in a clinical research setting.
Proven experience with creation of CDISC-compliant SAS data structures is expected. Regulatory submission experience in a clinical setting required. Ability to effectively collaborate, communicate, and influence throughout all levels of the organization. Strong leadership abilities are expected.

Contact: Nelson Joseph
email: njoseph@inventivclinical.com
office: 1800 256 4625 ext:21786

February

Senior Director & Multi-Therapeutic Area Site Head, Clinical Biostatistics, Wyeth Pharmaceuticals

A WORD version of the poster can be found here.

Senior Director & Multi-Therapeutic Area Site Head, Clinical Biostatistics
Wyeth Pharmaceuticals
Collegeville, Pennsylvania (Philadelphia, PA)
Requisition #13418

At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business.

Job Summary

The primary responsibility of the Senior Director is to provide guidance and direction to multiple Therapeutic Areas (TA) of the Global Biostatistics and Programming Department (GB&P). This includes resource allocation, recruitment and hiring, process improvement initiatives, procedures for maintaining a high level of collaboration with our clients, and technical and project related oversight for high priorities. The Senior Director will interact frequently with collaborators in GCT, Regulatory, key external leaders within academia, regulatory agencies and the industry, and Project management. The incumbent will participate on the Global Biostatistics & Programming Leadership Team and serve on various governance bodies in place of the VP/AVP of Biostatistics as needed.

Requirements

*Masters Degree, preferably with a Biostatistics, Statistics or related field major.
*13 years of related experience with a Doctorate Degree or 17 years of related experience with a Masters Degree.
*Demonstrated track record of technical accomplishments and leadership within pharmaceutical or related industry R&D.
*Experience in researching and applying statistical methods for pharmaceutical applications, i.e., clinical and nonclinical trials.
*Significant leadership and/or people management experience.
*Excellent written and oral communication abilities.

If you are not viewing this from our career web site, go to https://wyeth.recruitmax.com/main/careerportal/login.cfm, click on the "Job Search" tab, use Keywords: "13418" for a search, click on the "Job Title" link and then "Apply To This Job" at the end of the page. If you are unsure whether or not you already have a candidate profile in our database, request your forgotten password before attempting to create a new one. Please make sure that you have both a text version of your resume in the appropriate field as well a Word version attached to your profile.

Wyeth is an Equal Opportunity Employer, M/F/D/V.

Senior Level statistician at The Dominion Research Group, Inc.

A WORD version of the poster can be found here.

SUMMARY: Provide statistical and analytical support for pre-clinical research, pre-market, post-approval, marketing, and outcome studies. Provide statistical consultations to function groups of clinical research, regulatory, marketing, product development, health economics/reimbursement, and management.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Comply with appropriate regulatory requirements and follow regulatory guidance, use sound scientific/statistical principles and judgment, and serve as a resource of consultation for clinical research and development.
  • Participate in developing and refining objectives, endpoints, and measurements clinical studies.
  • Consult with management and appropriate personnel to determine study assumptions for calculating sample sizes and determine the sample sizes, as well as help assess the risk factors to study success (regulatory approval of investigational products).
  • Develop and document analysis plans by employing both Bayesian and frequentist methodologies, data forms, and procedures for clinical studies.
  • Participate in developing study protocols.
  • Support for clinical data publications, including directing and executing statistical analyses; interpreting results; authoring methodological and statistical sections of manuscripts; reviewing and approving abstracts, presentations, manuscripts, and other study reports; and ensuring high quality of publications.
  • Work with clinical data management personnel to develop specifications for database designs that assure quality, integrity, and timely availability of data.
  • Participate in interacting with outside statistical consultants.
  • Determine optimal approaches to collecting, analyzing, and presenting data for presentations and publications.
  • Perform and interpret interim and final analyses of data in support of regulatory submissions, including writing statistical reports.
  • Perform and interpret ad hoc analyses for the requests made from internal and external sources.
  • Validate statistical programs and prepare appropriate documentations.
  • Provide support for interactions and presents to management and reviewers at FDA and other regulatory agencies.
  • Interpret results of analyses and defend statistical methods employed, including frequentist and Bayesian paradigms.
  • Research and develop innovative statistical methodologies, including Bayesian statistics, for clinical, post-approval, and epidemiological studies.
  • Remain abreast of new developments in statistical methodology and clinical/outcome research.
  • Mentor junior statisticians or statistical analysts.
  • Perform any other activities upon request from management.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE:

Masterís degree in statistics or biostatistics from an accredited college or university and a minimum of three (3) years of pharmaceutical and/or medical device industry or clinical research experience is required; or .Ph.D. in statistics or biostatistics with a minimum of one year related experience.

Preferred:
  • Prior experience with FDA and other regulatory submissions
  • Prior experience in SAS programming to include SAS/Base, SAS/Macro, SAS/Graph, SAS/Access, and SAS/STAT
OTHER SKILLS and ABILITIES:
  • Capability of using S-Plus and WinBUGS for Bayesian analyses and MCMC simulations
  • In-depth knowledge of clinical research methodology, FDA and ICH regulations, and submission process
  • Ability to prioritize and handle multiple tasks concurrently
  • Ability to work with minimum supervision and handle multiple projects simultaneously
  • Superior interpersonal, written communication, time management, and organizational skills.
  • Proficient with personal computer software (Familiarity with Oracle/Clinical a plus)
  • Some overnight travel required.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to reach with hands and arms. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Statistics Manager at The Dominion Research Group, Inc.

A WORD version of the poster can be found here.

SUMMARY: Responsible for the coordination and conduct of statistical activities, including pre-clinical research, pre-market, post-approval, marketing, and outcome studies.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Comply with appropriate regulatory requirements and follow regulatory guidance, use sound scientific/statistical principles and judgment, and serve as a resource of consultation for clinical research and development.
  • Develop and refine objectives for pre-clinical, clinical, and post-approval studies.
  • Consult with management and appropriate personnel to develop study designs.
  • Consult with management and appropriate personnel to determine study assumptions for calculating sample sizes and determine the sample sizes, as well as help assess the risk factors to study success (regulatory approval of investigational products).
  • Research and develop appropriate statistical methodologies for pre-clinical research, clinical, and post- approval studies.
  • Develop and document analysis plans by employing both Bayesian and frequentist methodologies, data forms, and procedures for clinical studies.
  • Participate in developing study protocols.
  • Support for clinical data publications, including directing and executing statistical analyses; interpreting results; authoring methodological and statistical sections of manuscripts; reviewing and approving abstracts, presentations, manuscripts, and other study reports; and ensuring high quality of publications.
  • Perform and interpret interim and final analyses of data in support of regulatory submissions.
  • Review and approve specifications for database designs that assure quality, integrity, retrievability, and timely availability of data.
  • Determine optimal approaches to collecting, analyzing, and presenting data for presentations and publications.
  • Interact with and present to management and reviewers at FDA and other regulatory agencies and author answers to regulatory questions.
  • Interpret results of analyses and defend statistical methods employed, including frequentist and Bayesian paradigms.
  • Stay abreast with new developments in statistical methodology, attend scientific meetings, and conduct/ organize statistical research including Bayesian statistics to meet particular needs of clinical studies.
  • Interact with outside statistical consultants.
  • Develop and update appropriate work instructions (SOPs) with regard to statistical and related activities.
  • Manager statistical activities; plan staffing, resources, and budget; and supervise/mentor statisticians.
  • Prioritize and execute multiple tasks concurrently and ensure tasks completed based on agreed timelines.
  • Other activities associated with analytical efforts as needed.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE:

Masterís degree in statistics or biostatistics is required. Ph.D. degree in statistics or biostatistics is strongly preferred. An M.S. with more than seven years, or a Ph.D. with more than four years, of pharmaceutical and/or medical device industry or clinical research experience is preferred. Training in Bayesian statistics is highly preferred, although not required. Prior experience with FDA and other regulatory submissions is essential. Prior management experience in biostatistics is plus.

OTHER SKILLS and ABILITIES:
  • Proficiency in SAS programming.
  • Capability of using S-Plus and WinBUGS for Bayesian analyses and simulations.
  • Superior interpersonal, written and oral communication, time management, and organizational skills.
  • Experience with personal computer software (MS Office).
  • In-depth knowledge of clinical research methodology, FDA and ICH regulations, and submission process.
  • Some overnight travel required.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to reach with hands and arms. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually quiet to moderate.