Midsized pharmaceutical company in Bridgewater area has an immediate need for an experienced Data Manager.
Details are as follows:
General Summary:Contribute to data management activities related to drug product development for assigned compounds or indications. Collaborate with internal biostatistics, Clinical Operations, and CRO data management and biostatistics.Essential Duties &
Responsibilities:
1. Lead efforts for eCRF design with Biostatistics and Clinical Operations and coordinate a final CRF, edit checks, data review and data extracts.
2. Review published CRFs and hyperlinks in support of FDA, EMEA or worldwide submissions
3. Review data definition files and other DM or biostatistical components of a submission to ensure content meets Regulatory agency submission requirements
4. Review CRF for consistency with Company standards
Essential Knowledge, Skills, & Experience:
1. B.S. required. Preference in science or computers
2. 6-8 years of data management experience with3 years in a project lead capacity
3. Must have at least 2 years of Oncology data management experience
4. Strong project management experience within data management
5. Proven ability to manage multiple vendors on a given study (i.e., CROs, EDC, Lab vendors)
6. The ability to interface with Medical Writing, Clinical, Statistics, and Drug Safety
7. Must attend and/or present at investigator meetings on behalf of Company Systems
8. Excellent communication and writing skills
9. Knowledge of FDA, EMEA and ICH guidelines and regulations covering clinical trials, statistics, and data management preferred10. Knowledge of EDC and CDISC preferred
Please send all resumes to sruesch@csg-inc.com
Tuesday, October 6, 2009
Manager of Biostatistics - Pharmaceutical Client in Bridgewater, NJ area
Manager of Biostatistics - Pharmaceutical Client in Bridgewater, NJ area
send resumes to sruesch@csg-inc.com
Midsized pharmaceutical company in Bridgewater area has an immediate need for a Senior Manager/Manager of Biostatistics. No direct reports. Details are as follows:
Manage and lead biostatistical activities related to drug product development for assigned compounds, indications or studies. Mentor statistical and programming professionals in biostatistics. Collaborate with internal Data Management professionals and manage Data Management and Biostatistical personnel at CROs.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Collaborate with Biostatistics, Clinical and Medical Writing on clinical trial protocols, case report forms, statistical analysis plans, and other study related activities.
2. Assume responsibility to provide statistical services in drug development
3. Provide statistical support for submission of marketing applications (e.g., NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies
4. Collaborate with internal Data Management professionals and manage Data Management and Biostatistical personnel at CROs
5. Collaborate with development partners
6. Mentor statisticians/programmers/consultants
7. Lead statistical activities for assigned clinical trials
ESSENTIAL, KNOWLEDGE, SKILLS, EXPERIENCE:
1. M.S. required in Statistics, Biostatistics, Public Health or related field; PhD recommended
2. Five years experience in clinical trials including marketing applications (NDA/BLA) submissions, including FDA and EMEA experience
3. Excellent communication and writing skills
4. Experience with cancer clinical trials and/or time-to-event data is preferred
5. Excellent programming skills, especially in SAS. S-Plus is a plus
6. Knowledge of FDA, EMEA and ICH guidelines and regulations covering clinical trials, statistics, and data management
7. Knowledge of EDC and CDISC preferred
send resumes to sruesch@csg-inc.com
Midsized pharmaceutical company in Bridgewater area has an immediate need for a Senior Manager/Manager of Biostatistics. No direct reports. Details are as follows:
Manage and lead biostatistical activities related to drug product development for assigned compounds, indications or studies. Mentor statistical and programming professionals in biostatistics. Collaborate with internal Data Management professionals and manage Data Management and Biostatistical personnel at CROs.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Collaborate with Biostatistics, Clinical and Medical Writing on clinical trial protocols, case report forms, statistical analysis plans, and other study related activities.
2. Assume responsibility to provide statistical services in drug development
3. Provide statistical support for submission of marketing applications (e.g., NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies
4. Collaborate with internal Data Management professionals and manage Data Management and Biostatistical personnel at CROs
5. Collaborate with development partners
6. Mentor statisticians/programmers/consultants
7. Lead statistical activities for assigned clinical trials
ESSENTIAL, KNOWLEDGE, SKILLS, EXPERIENCE:
1. M.S. required in Statistics, Biostatistics, Public Health or related field; PhD recommended
2. Five years experience in clinical trials including marketing applications (NDA/BLA) submissions, including FDA and EMEA experience
3. Excellent communication and writing skills
4. Experience with cancer clinical trials and/or time-to-event data is preferred
5. Excellent programming skills, especially in SAS. S-Plus is a plus
6. Knowledge of FDA, EMEA and ICH guidelines and regulations covering clinical trials, statistics, and data management
7. Knowledge of EDC and CDISC preferred
Contract Non-Clinical Statistician for BMS in Wallingford, VT
Large pharmaceutical company in greater New Haven area has an immediate need for a contract based Non Clinical Biostatistician.
PhD in Statistics-2 years of non clinical statistics experience in a pharma industry is required. MS in Statistics-4 years of non clinical statistics experience is required.
Selected candidate will collaborate with Scientists in Drug Discovery and Biologics Development.
Work with Scientists to design experiments, develop/validate bioassays, prepare reports, and implement analyses in lab software.
Previous experience with experimental design, multivariate statistics, general linear models, and mixed models is required.
Must also have experience with SAS. Prefer previous SPlus and JMP exp as well.
Contract is inisially for 6 months, but can be extended up to 2 years. W-2 Max rate is $70/hour.
Send resumes and inquiries to sruesch@csg-inc.com
PhD in Statistics-2 years of non clinical statistics experience in a pharma industry is required. MS in Statistics-4 years of non clinical statistics experience is required.
Selected candidate will collaborate with Scientists in Drug Discovery and Biologics Development.
Work with Scientists to design experiments, develop/validate bioassays, prepare reports, and implement analyses in lab software.
Previous experience with experimental design, multivariate statistics, general linear models, and mixed models is required.
Must also have experience with SAS. Prefer previous SPlus and JMP exp as well.
Contract is inisially for 6 months, but can be extended up to 2 years. W-2 Max rate is $70/hour.
Send resumes and inquiries to sruesch@csg-inc.com
New Perm position in NYC for SAS Programmer!!
New Perm position in New York City, NY (relocation can be provided!)
Send resumes to sruesch@csg-inc.com
TITLE: Statistical Database Manager, Reproductive Health Program
JOB DESCRIPTION
The statistical database manager will play a key senior role with the data management and statistical group and will be responsible for performing specific data management, programming, and statistical analysis functions that will ensure timely progression of activities associated with Reproductive Health program (RH) clinical trial data. This individual will contribute to the organization of data for a new drug application (NDA) for submission to the US Food and Drug Administration and other regulatory bodies.
RESPONSIBILITIES
Individually and in collaboration with the data management and statistical teams, perform relevant aspects of data management for selected RH clinical protocols within the Center for Biomedical Research (CBR).
Provide overall support to data management personnel for selected studies, including building SAS-based edit checks and SAS-based data cleaning programs.
In collaboration with senior statistical scientist, assume responsibility for outlining and developing required statistical analysis (including specifications) and/or statistical analysis plans (SAPs) for Phase 2 and 3 studies or other statistical analysis requirements (e.g., analyses needed for internal/external meetings and publications).
Contribute to the development of tables and reports/presentations/publications (e.g., annual study reports to regulatory bodies).
Collaborate with statistical and data management groups to define statistical/analytic table shells in SAS programming language as required for completing study reports (includes writing SAS programs to produce defined statistical/analytic tables).
Be responsible for coordination with senior scientist, data manager, medical writer, and director of clinical development to meet timelines and deadlines for various clinical trial reports, including timelines for data cleaning and data lock for recently completed Phase 3 clinical trial.
Be responsible for data archiving in accordance with regulatory requirements.
Contribute to the development of instruments needed for clinical trials, including case report forms (CRFs), questionnaires/diaries involving clinical trial participants, various tables and reports/presentations as needed (e.g., annual study reports to regulatory bodies).
Develop and maintain internal operation manual to ensure the quality and efficiency of the data management activities, including departmental standard operating procedures (SOPs) as needed.
QUALIFICATIONS
Master's degree/Ph.D. in computer science and/or statistics with a minimum of five years' clinical data management and statistical analysis experience.
Data management and statistical analysis experience with investigational pharmaceutical products (experience with women's health products preferred).
Experience and expertise with data management software (knowledge of DataFax is a plus).
Demonstrated ability to develop and write data management and statistical analysis plans.
Experience in preparing data for publications and writing for publications.
Experience with regulatory requirements, including FDA, regarding validity of data and data presentations required for submission of NDAs and annual reports.
Experience with tasks of clinical trial statistician, including ability to apply/critique appropriate statistical analysis programs for contraceptive trials.
Detail-oriented with good analytical skills and in-depth knowledge of and experience with SAS.
Experience with data archiving.
Demonstrated negotiation and interpersonal skills in order to interact with individuals across all levels of the Council's global organization; effective oral and written communication skills are essential.
Knowledge of and experience with MedDRA and/or WHOART coding is highly desirable.
Strong sense of professional responsibility and work ethic.
Send resumes to sruesch@csg-inc.com
TITLE: Statistical Database Manager, Reproductive Health Program
JOB DESCRIPTION
The statistical database manager will play a key senior role with the data management and statistical group and will be responsible for performing specific data management, programming, and statistical analysis functions that will ensure timely progression of activities associated with Reproductive Health program (RH) clinical trial data. This individual will contribute to the organization of data for a new drug application (NDA) for submission to the US Food and Drug Administration and other regulatory bodies.
RESPONSIBILITIES
Individually and in collaboration with the data management and statistical teams, perform relevant aspects of data management for selected RH clinical protocols within the Center for Biomedical Research (CBR).
Provide overall support to data management personnel for selected studies, including building SAS-based edit checks and SAS-based data cleaning programs.
In collaboration with senior statistical scientist, assume responsibility for outlining and developing required statistical analysis (including specifications) and/or statistical analysis plans (SAPs) for Phase 2 and 3 studies or other statistical analysis requirements (e.g., analyses needed for internal/external meetings and publications).
Contribute to the development of tables and reports/presentations/publications (e.g., annual study reports to regulatory bodies).
Collaborate with statistical and data management groups to define statistical/analytic table shells in SAS programming language as required for completing study reports (includes writing SAS programs to produce defined statistical/analytic tables).
Be responsible for coordination with senior scientist, data manager, medical writer, and director of clinical development to meet timelines and deadlines for various clinical trial reports, including timelines for data cleaning and data lock for recently completed Phase 3 clinical trial.
Be responsible for data archiving in accordance with regulatory requirements.
Contribute to the development of instruments needed for clinical trials, including case report forms (CRFs), questionnaires/diaries involving clinical trial participants, various tables and reports/presentations as needed (e.g., annual study reports to regulatory bodies).
Develop and maintain internal operation manual to ensure the quality and efficiency of the data management activities, including departmental standard operating procedures (SOPs) as needed.
QUALIFICATIONS
Master's degree/Ph.D. in computer science and/or statistics with a minimum of five years' clinical data management and statistical analysis experience.
Data management and statistical analysis experience with investigational pharmaceutical products (experience with women's health products preferred).
Experience and expertise with data management software (knowledge of DataFax is a plus).
Demonstrated ability to develop and write data management and statistical analysis plans.
Experience in preparing data for publications and writing for publications.
Experience with regulatory requirements, including FDA, regarding validity of data and data presentations required for submission of NDAs and annual reports.
Experience with tasks of clinical trial statistician, including ability to apply/critique appropriate statistical analysis programs for contraceptive trials.
Detail-oriented with good analytical skills and in-depth knowledge of and experience with SAS.
Experience with data archiving.
Demonstrated negotiation and interpersonal skills in order to interact with individuals across all levels of the Council's global organization; effective oral and written communication skills are essential.
Knowledge of and experience with MedDRA and/or WHOART coding is highly desirable.
Strong sense of professional responsibility and work ethic.
New Perm SAS Programmer position in Southborough, MA
Midsized CRO with various stateside offices has an immediate need for 2 perm based Sr. Statistical (SAS) Programmers.
Resumes can be sent to sruesch@csg-inc.com
Details are as follows:
Job Details:
Under minimal supervision the Sr. Statistical Programmer performs complex design and programming tasks. Requires interfacing with intra and inter-departmental project team members.
ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING:
• Write and debug statistical programming in SAS, and StatXact to check and process data, generate tables, analyses, graphs, and data listings with an emphasis on the most programmatically challenging sections of the analysis system.
• Insure that project-specific derived dataset specifications and analysis programming specifications are complete and accurate.
• Coordinate project-specific statistical programming resources including (1) defining timelines for batches of data displays in conjunction with the Biostatistician, (2) allocating appropriate programming responsibilities which take into consideration each programmers level of knowledge and experience as well as opportunities for growth, and (3) reviewing programming code.
• Conceptualize, design, and implement programs and processes to standardize statistical programming across projects.
• Participate in the design of logic checks, data collection guidelines, information flow, analysis plans, and reports for clinical studies.
• Learn standard coding classification systems used for coding of medical procedures, medications, and adverse experiences.
• Attend project meetings to present status reports on accrual, case eligibility, dropouts, exclusions, adverse events, safety, data quality, information timeliness, and problem data.
• Interact with Database Developers, Data Managers, Monitors, other Statistical Programmers, and Biostatisticians.
• Conduct training for new Statistical Programmers.
• Assist in:- The definition of statistical programming conventions and procedures.- The evaluation of new software and enhancements to existing software.
• Document programming procedures and coding.
• Give feedback on problem data to project team.
• Follow Standard Operating Procedures for BBI.
• May also be involved in interviewing process for statistical programming candidates.
• Perform all other duties as assigned.
EDUCATION AND/OR EXPERIENCE:
• Bachelors in Statistics or related discipline, with a minimum of 4 years relevant experience; or Masters in statistics with a minimum of 3 years relevant experience.
• Preferred Qualifications:Advanced coursework. Experience in a CRO. Experience as a team and/or project lead. Experience in UNIX.
ESSENTIAL KNOWLEDGE, SKILLS & LICENSES:
• Excellent computer skills with extensive experience in SAS, and StatXact
• Excellent problem solving and organizational skills with ability to work in a high volume and strict deadline environment
• Excellent interpersonal skills
• Excellent verbal and written communications skills
• Ability to work independently and as a team member
Resumes can be sent to sruesch@csg-inc.com
Details are as follows:
Job Details:
Under minimal supervision the Sr. Statistical Programmer performs complex design and programming tasks. Requires interfacing with intra and inter-departmental project team members.
ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING:
• Write and debug statistical programming in SAS, and StatXact to check and process data, generate tables, analyses, graphs, and data listings with an emphasis on the most programmatically challenging sections of the analysis system.
• Insure that project-specific derived dataset specifications and analysis programming specifications are complete and accurate.
• Coordinate project-specific statistical programming resources including (1) defining timelines for batches of data displays in conjunction with the Biostatistician, (2) allocating appropriate programming responsibilities which take into consideration each programmers level of knowledge and experience as well as opportunities for growth, and (3) reviewing programming code.
• Conceptualize, design, and implement programs and processes to standardize statistical programming across projects.
• Participate in the design of logic checks, data collection guidelines, information flow, analysis plans, and reports for clinical studies.
• Learn standard coding classification systems used for coding of medical procedures, medications, and adverse experiences.
• Attend project meetings to present status reports on accrual, case eligibility, dropouts, exclusions, adverse events, safety, data quality, information timeliness, and problem data.
• Interact with Database Developers, Data Managers, Monitors, other Statistical Programmers, and Biostatisticians.
• Conduct training for new Statistical Programmers.
• Assist in:- The definition of statistical programming conventions and procedures.- The evaluation of new software and enhancements to existing software.
• Document programming procedures and coding.
• Give feedback on problem data to project team.
• Follow Standard Operating Procedures for BBI.
• May also be involved in interviewing process for statistical programming candidates.
• Perform all other duties as assigned.
EDUCATION AND/OR EXPERIENCE:
• Bachelors in Statistics or related discipline, with a minimum of 4 years relevant experience; or Masters in statistics with a minimum of 3 years relevant experience.
• Preferred Qualifications:Advanced coursework. Experience in a CRO. Experience as a team and/or project lead. Experience in UNIX.
ESSENTIAL KNOWLEDGE, SKILLS & LICENSES:
• Excellent computer skills with extensive experience in SAS, and StatXact
• Excellent problem solving and organizational skills with ability to work in a high volume and strict deadline environment
• Excellent interpersonal skills
• Excellent verbal and written communications skills
• Ability to work independently and as a team member
High Level Contract Biostatistician position in Summit NJ
We have an immediate need for a contract Biostatistician in Summit NJ
Contract pays top $$
Send all resumes to sruesch@csg-inc.com
Midsized pharmaceutical company in Summit, NJ has an immediate need for a contract Statistician.
Leased Worker shall perform the following Services with activities including but not limited to:
Statistical and Programming support to clinical studies in the Summit location.
Any other related tasks as may be required by department.
Skills/Knowledge Required:
· Masters degree in Statistics/Biostatistics and extensive experience analyzing data in sponsor or cro environments. PhD degree is preferable, but not required.
· Excellent written and oral communication skills required.
· Demonstrate ability to function in a team environment
· Proven ability to multi-task
· Minimum of 2 years of work experience in the pharmaceutical industry.
Contract pays top $$
Send all resumes to sruesch@csg-inc.com
Midsized pharmaceutical company in Summit, NJ has an immediate need for a contract Statistician.
Leased Worker shall perform the following Services with activities including but not limited to:
Statistical and Programming support to clinical studies in the Summit location.
Any other related tasks as may be required by department.
Skills/Knowledge Required:
· Masters degree in Statistics/Biostatistics and extensive experience analyzing data in sponsor or cro environments. PhD degree is preferable, but not required.
· Excellent written and oral communication skills required.
· Demonstrate ability to function in a team environment
· Proven ability to multi-task
· Minimum of 2 years of work experience in the pharmaceutical industry.
New Position - Program Director Biostatistics in Waltham, MA
NEW JOB IN WALTHAM, MA (perm up to 110K+ , relocation available!!)
Resumes can be sent to sruesch@csg-inc.com
JOB PURPOSE: The Program Director, Biostatistics is responsible for advanced statistical programming and analysis of Medicare/MassHealth co-operative projects and for contracts with the Center for Medicare and Medicaid Services. The Program Director assists staff in analyzing data to improve health outcomes and health service delivery, designing evaluation strategies, developing proposals and executing new strategies, and creating new projects.
ESSENTIAL/KEY RESPONSIBILITY AREAS:
Biostatistical Analysis
· Applies knowledge of statistical theory to select appropriate statistical methods.
· Analyzes and interprets each project’s data, using categorical data analysis and multivariate analysis techniques such as logistic regression, ANOVA, and model development.
· Conducts exploratory research to develop sampling methodology and calculate sample size.
· Uses sampling techniques to draw statistically valid samples.
· Answers questions regarding use of statistical techniques as posed by Masspro staff.
· Writes technical notes & result summaries for all reports.
· Assists in developing grant proposals including writing statistical analysis sections.
· Conducts analysis to define, develop, validate and refine quality measures as well as creating specifications for quality measures.
Program Management
· Develops standardized approaches to programming data.
· Oversees and regularly reports on an auditable QA/QC program.
· Develops and monitors a cohesive project plan for the unit which balances multiple deliverables from multiple contractual arrangements.
· Assures that all work products are readily available to necessary users.
· Communicates regularly with customers.
All Other Duties As Assigned
QUALIFICATIONS:
· Masters degree in Biostatistics, Statistics, or Epidemiology; Ph.D. preferred.
· A minimum of 10 years of work experience in programming, data manipulation and statistical analysis in a healthcare environment.
· A working knowledge of SAS, and proficiency in developing macros, use of SQL and relational databases in a client server environment.· Some knowledge of MS Access, Visual Basic or other programming language preferred.
· Experience using SUDAAN or SPSS software preferred.
SKILLS and COMPETENCIES:
Technical Skills:
· Working knowledge of SAS programming including Base SAS and macros, SAS/Graph and proc SQL preferred.
· Ability to program using SAS ODS to produce professional quality data reports.
· Extensive knowledge using Microsoft Excel.
· Knowledge and use of project management tools and approaches
Cognitive/Conceptual/Reasoning/Decision Making Skills:
· Excellent analytical and problem solving skills.
· Ability to troubleshoot.
· Possesses excellent organizational skills and capable of multi-tasking.
· Adaptive, able to deal with ambiguity and frequently changing requirements.
Resumes can be sent to sruesch@csg-inc.com
JOB PURPOSE: The Program Director, Biostatistics is responsible for advanced statistical programming and analysis of Medicare/MassHealth co-operative projects and for contracts with the Center for Medicare and Medicaid Services. The Program Director assists staff in analyzing data to improve health outcomes and health service delivery, designing evaluation strategies, developing proposals and executing new strategies, and creating new projects.
ESSENTIAL/KEY RESPONSIBILITY AREAS:
Biostatistical Analysis
· Applies knowledge of statistical theory to select appropriate statistical methods.
· Analyzes and interprets each project’s data, using categorical data analysis and multivariate analysis techniques such as logistic regression, ANOVA, and model development.
· Conducts exploratory research to develop sampling methodology and calculate sample size.
· Uses sampling techniques to draw statistically valid samples.
· Answers questions regarding use of statistical techniques as posed by Masspro staff.
· Writes technical notes & result summaries for all reports.
· Assists in developing grant proposals including writing statistical analysis sections.
· Conducts analysis to define, develop, validate and refine quality measures as well as creating specifications for quality measures.
Program Management
· Develops standardized approaches to programming data.
· Oversees and regularly reports on an auditable QA/QC program.
· Develops and monitors a cohesive project plan for the unit which balances multiple deliverables from multiple contractual arrangements.
· Assures that all work products are readily available to necessary users.
· Communicates regularly with customers.
All Other Duties As Assigned
QUALIFICATIONS:
· Masters degree in Biostatistics, Statistics, or Epidemiology; Ph.D. preferred.
· A minimum of 10 years of work experience in programming, data manipulation and statistical analysis in a healthcare environment.
· A working knowledge of SAS, and proficiency in developing macros, use of SQL and relational databases in a client server environment.· Some knowledge of MS Access, Visual Basic or other programming language preferred.
· Experience using SUDAAN or SPSS software preferred.
SKILLS and COMPETENCIES:
Technical Skills:
· Working knowledge of SAS programming including Base SAS and macros, SAS/Graph and proc SQL preferred.
· Ability to program using SAS ODS to produce professional quality data reports.
· Extensive knowledge using Microsoft Excel.
· Knowledge and use of project management tools and approaches
Cognitive/Conceptual/Reasoning/Decision Making Skills:
· Excellent analytical and problem solving skills.
· Ability to troubleshoot.
· Possesses excellent organizational skills and capable of multi-tasking.
· Adaptive, able to deal with ambiguity and frequently changing requirements.
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