Verna Scientific, a Makro Company
Name of Position: Sr. Statistical Programmer
Job Location: Palo Alto, CA
Job Type: Contract
Duration: 8 months
Abstract of Position:
In this
role, you will provide technical and statistical programming expertise for all
Study Management Teams (SMTs) within assigned clinical programs.
Responsibilities include developing software to generate clinical study
reports, typically using SAS; managing software development in support of
regulatory, publication and business events; performing review of protocol and
case report forms (CRF); identifying and resolving data monitoring, management
and review issues; and identifying and resolving analysis file structure,
software development and clinical reporting issues within a clinical study.
Additionally, you will be relied upon to establish programming standards for
all assigned study management teams and ensure compliance with standards
established at the program level; perform programming tasks to support planned
analysis and clinical reporting; ensure compliance with Biostatistics Computing
Environment (BCE) standards and assist the BCE administrator in establishing
new standards; and comply with analysis standards at the study and program
levels as well as administer and comply with all relevant SOPs, policies and
guidelines. At the senior level, this position will provide technical advice to
statistical programmers or programming contractors; establish and maintain
programming standards across all studies within a clinical program; provide
specifications to clinical programming for the creation of Generic Data Models
(GDMs); and perform user acceptance testing of GDMs.
KNOWLEDGE/SKILL/EDUCATION REQUIREMENTS:
Typically requires a BS/BA or MS/MA degree or equivalent in Statistics,
Computer Science, or other scientific or analytical field, and a minimum of 5
years experience in the pharmaceutical industry and knowledge of the drug
development process. Must have excellent programming skills in SAS with a
minimum of 5 years experience. Knowledge of Oracle Clinical database is
preferred. Must have excellent project management skills. Excellent
communication skills required. Experience in teams setting and ability to
effectively communicate at meetings and in written reports required.
MAJOR RESPONSIBILITIES/ACCOUNTABILITIES:
A. Essential functional duties of the position—
· Participate in all assigned study management teams, as an active member, to provide technical and statistical programming related expertise and advice to other members on the study management teams.
· Perform protocol review and provide input to case report form (CRF) design, identify and resolve data issues associated with assigned study management team(s).
· Identify and resolve analysis file structure, software development, and clinical reporting issues within a clinical study. Create the datasets specification according to the Generic Data Model in cooperation with clinical programming and perform user acceptance testing of GDMs.
· Plan software development activities and manage software development to support study management team planned events across all studies in a clinical program.
· Establish programming standards for all assigned study management teams, integrated analyses across all studies within a clinical program. Ensure analysis standards are in compliance with standards at the study and program levels.
· Program, validate and document data tabulations, graphics and statistical evaluations for efficacy and safety. Ensure that programs developed for specific projects/protocols are sufficiently portable to allow application to other projects and protocols.
· Ensure programming tasks are completed timely to support all planned analysis and clinical reporting for all studies within assigned clinical program(s) and integrated safety and efficacy summaries across a clinical program.
· Comply with Biostatistics Computing Environment (BCE) standards and practices and may assist BCE administrator to establish new standards and practices.
· Administer and comply with all relevant SOPs, policies, and guidelines.
· Train users to apply statistical programming standards and standard software. Assist users to resolve individual technical difficulties with the standard software.
· Participate in and contribute to internal training programs.
· Communicate effectively to study management team members, other statistical programmers and members in PDMB to ensure all clinical reporting requirements are clearly communicated and agreed upon.
· Provide technical advice to Statistical Programmers and/or programming contractor(s) assigned to the same clinical study or program(s).
· Deputizes upon request for the department management.
The Essential results expected from this position are:
· Effective technical and statistical programming support for all study management teams associated with the assigned clinical program(s), including programming for study analysis and reporting of clinical trials, advice in protocol writing and CRF design, database definition and data quality plan, assistance in resolving study conduct and data management issues, and support for all study management team planned events across all studies in a clinical program.
· Effective implementation of clinical program(s) standards to study level to support data monitoring, data management, statistical analysis, and clinical reporting.
· Effective resource planning for assigned clinical studies and/or program(s). Effective communication to Statistical Programming Manager on project status and resource issues.
· Effective communication to study management team members, clinical team statistician, and other members in PDMB to ensure all clinical reporting requirements are clearly communicated and agreed upon.
· Compliance with BCE standards and practices and related SOPs, policies, and guidelines.
B. Other responsibilities/accountabilities (marginal functions) —
· Takes responsibility for planning, development, validation, documentation, and maintenance of generic tools.
Pay Rate/Salary: Open
Skills/Education Requirements:
· Typically requires a BS/BA or MS/MA degree or equivalent in Statistics, Computer Science, or other scientific or analytical field, and a minimum of 5 years experience in the pharmaceutical industry and knowledge of the drug development process.
· Must have excellent programming skills in SAS with a minimum of 5 years experience.
· Knowledge of Oracle Clinical database is preferred.
· Must have excellent project management skills.
· Excellent communication skills required.
· Experience in teams setting and ability to effectively communicate at meetings and in written reports required.
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 3/3/2008