Verna Scientific, a Makro Company
Name of Position: Sr Manager Biostatistician
Job Location: San Diego, CA
Job Type: Permanent
Duration: Full Time
Abstract of Position:
Sr. Manager, Biostatistics responsible for providing guidance to statisticians and statistical programmers of Biostatistics in providing the statistical support to client clinical development projects, and on assignment basis as needed to other client functional areas.
Position Responsibilities:
· Provides guidance to statistician and programmers on statistical analysis and programming.
· Provides statistical input to clinical development protocol and CRF design.
· Develops and reviews Statistical Analysis Plan, Mock-Up Tables, and Analysis Datasets Specification documents for clinical study protocol.
· Ensures adherence to project timelines.
· Develops and administers Biostatistics group budget.
· Selects, develops and evaluates personnel to ensure the efficient operation of the function.
· Monitors contract research organization's (CRO) progress on the adherence of project timelines and the quality of deliverables.
· Develops detailed project task lists and timelines.
· Ensures quality of the final statistical analysis results.
· Tracks progress toward completion of analytical programs, and works with the Sr. Director of Biometrics to adjust resources as necessary to most effectively and efficiently address Biometrics' priorities.
· Interfaces with consultants and other client functionaries on statistical or data analysis related issues.
· Responsible for the conduct and quality of assigned statistical analyses.
· Responsible for implementation of client SOPs.
· Works with Biometrics Management in developing the Biometrics Infrastructure.
Pay Rate/Salary: Open
Skills/Education
Requirements:
Masters/Ph.D. in
Statistics, or equivalent with a minimum of 10 years related experience
(statistical analysis of pharmaceutical clinical trial results) with a Masters
or 8 years related experience with a Ph.D. Requires 3 years previous
supervisory and managerial experience. Experience with Survival Model
preferred.
Number of Openings: 2
Contact Person: Neil
Telephone, E-mail, Postal Address: Neil Mahapatra
neil.mahapatra@vernascientific.com
Tel: 973-481-0100 Ext: 3020
Fax: 973-481-1020
Verna Scientific
a Makro Company
One
Washington Park, Suite 1502, Newark, NJ 07102
Offices: Illinois, Pennsylvania
Posted 2/5/2008
Name of Position: Sr Biostatistician
Job Location: Northridge, Los Anageles, CA
Job Type: Permanent
Duration: Full Time
Abstract of Position:
Description
Responsible for ensuring that statistical support provided for the design,
analysis and reporting of clinical studies is based on sound statistical
principles and in compliance with regulatory guidelines.
Position Responsibilities:
§ Interact with multidisciplinary team to design, develop, and review clinical
protocols to meet business strategy.
§ Proficiency in planning, preparing and executing statistical analysis for
clinical trials
§ Interpret results from analysis of clinical data and participates in the
preparation of study reports.
§ Interacts with FDA statistical and medical reviewers to negotiate appropriate
study design, address specific issues, and defend analytic approach.
§ Provides statistical support to other departments including manufacturing,
engineering and marketing
Pay Rate/Salary: Open
Skills/Education
Requirements:
Basic Qualifications
§ PhD/MS in
Biostatistics with a minimum of 4 years in the biotech/device/pharmaceutical
industry.
§ Management or direct supervisory experience.
§ Expertise in statistical principles, methods, and procedures and the ability
to instruct others in these areas.
§ Ability to create novel statistical techniques, as needed, to interpret
complex data, and the ability to demonstrate the mathematical validity of these
techniques.
§ Extensive knowledge of regulatory guidelines and the application to clinical
trials
§ Excellent verbal and written communication skills and ability to make
effective presentations
Number of Openings: 2
Contact Person: Neil
Telephone, E-mail, Postal Address: Neil Mahapatra
neil.mahapatra@vernascientific.com
Tel: 973-481-0100 Ext: 3020
Fax: 973-481-1020
Verna Scientific
a Makro Company
One
Washington Park, Suite 1502, Newark, NJ 07102
Offices: Illinois, Pennsylvania
Posted 12/18/2007
Name of Position: Sr SAS Programmer
Job Location: Irvine, CA
Job Type: Permanent
Duration: Full Time
Abstract of Position:
Brief summary:
Develop SAS programs for data cleaning and reporting. Create customized
listings/reports with SAS. Provide statistical programming support under the
direction of the senior staff for the creation and maintenance of analysis data
sets, tables, listings, and figures.
Responsibilities:
§ Create derived analysis datasets.
§ Execute analyses specified in the Statistical Analysis Plan (SAP) under the
guidance of the project statistician.
§ Act as primary programmer to produce tables, listings, and figures (TLFs) for
the clinical study report (CSR) and ad-hoc reports.
§ Act as secondary programmer to validate SAS programs that produce derived
analysis datasets and data analyses and ad-hoc reports.
§ Assist Clinical Data Management (CDM) group to design or review database
structures, and provide CRF listings for edit check purposes.
§ Develop and Refine SOPs for data handling, programming and system validation.
Pay Rate/Salary: Open
Skills/Education
Requirements:
Basic Qualifications
Qualifications,
Education and Experience:
§ Degree in Life Sciences, Computer Science, Statistics, or related field
§ General knowledge of medical terminology and clinical trial methodologies
§ Bachelor's degree with a minimum 6yrs SAS programming experience or a Master's
or equivalent degree with 4 yrs SAS programming experience
§ Strong SAS programming skills with proficiency in SAS/Base, SAS Stat, and SAS
Macros with basic understanding of SAS/Graph
§ Prior experience working in the pharmaceutical/Biotechnology industry
§ Ability to work independently
§ Clear verbal and written communication skills; able to work with other cross
function areas and CROs
§ Excellent collaborative skills and the ability to manage complexity and
change in a dynamic environment
Number of Openings: 2
Contact Person: Neil
Telephone, E-mail, Postal Address: Neil Mahapatra
neil.mahapatra@vernascientific.com
Tel: 973-481-0100 Ext: 3020
Fax: 973-481-1020
Verna Scientific
a Makro Company
One
Washington Park, Suite 1502, Newark, NJ 07102
Offices: Illinois, Pennsylvania
Posted 11/26/2007
Name of Position: Sr SAS Programmer
Job Location: Northridge, CA
Job Type: Permanent
Duration: Full Time
Abstract of Position:
Provide advanced technical expertise as part of the Bio-Statistical team to
develop and maintain programs to meet clinical studies’ needs. Plan
and lead the development of project-related solutions to the full scope of
statistical programming tasks. Provide technical expertise to the Data
Management/ Bio-Statistical Group.
Position
Responsibilities
• Plans and coordinates programming, testing, and documentation of statistical
programs for use in creating statistical tables, graphics, and listing
summaries.
• Programs analysis database manipulations and transfers of data for
internal and external clients. May integrate databases from multiple
studies or sources.
• Develops listing and table specifications with study Biostatistician.
• Interacts with Data Management and Biostatistics staff to negotiate
timelines, responsibilities, and deliverables. May mentor other team
members in departmental procedures and developing technical expertise.
• May assist in developing, revising, and maintaining Standard Operating
Procedures and Work Instructions. Programs, tests, and documents statistical
programs and tools in accordance with BioStatistics’ standards and
validation procedures.
• Performs other duties as directed by Statistical Programming
management.
Pay Rate/Salary: Open
Skills/Education
Requirements:
Basic Qualifications
•
Bachelor level degree
• 4 yrs work experience
• Knowledge of Base SAS/STAT, Excel, and ASCII
• Excellent organizational, interpersonal, communication, and technical
database skills are essential.
Desired/Preferred
Qualifications
•
Bachelor’s degree in computer science, biostatistics or related field
with 4 yrs of relevant work experience
• Master’s
degree with 2+ years of relevant work experience.
• Advanced
knowledge of Base SASŪ, STAT, SAS Macro language, SAS/SQL, and
SAS/GRAPH.
•
Capable of Import and Export functionality using SAS such as Create SAS dataset
from various external sources
• Experience
using ORACLE, EXCEL, ASCII and text files
• Experience in
producing external files and reports employing various SAS procedures,
including tables, graphs, and listings.
• Proficient in
the following procedures: Proc Freq, Mean, ODS, Print, Report, Summary,
Transpose, SQL, and Tabulate
• Solid
understanding of clinical device/drug development process is preferred.
• Solid
programming skill sets
Number of Openings: 2
Contact Person: Neil
Telephone, E-mail, Postal Address: Neil Mahapatra
neil.mahapatra@vernascientific.com
Tel: 973-481-0100 Ext: 3020
Fax: 973-481-1020
Verna Scientific
a Makro Company
One
Washington Park, Suite 1502, Newark, NJ 07102
Offices: Illinois, Pennsylvania
Posted 10/31/2007