BioMarin Pharmaceutical, Inc.
At BioMarin, we recognize and value each employees contribution toward reaching our corporate missionto develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them.
Today, with three products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us.
BioMarin is pleased to offer a comprehensive benefits program that extends beyond that commonly seen in the biotech industry. Currently, there are no out of pocket costs for eligible employees and their eligible dependents.
NAME OF POSITION: Senior Statistical Programmer Analyst
LOCATION: Novato/Brisbane, California-San Francisco 94949
Position type: Full time
Reports To: Associate Director, SAS Systems and Statistical Programming
Summary:
The Senior Statistical Programmer Analyst applies advanced programming techniques and leads the planning, design, development, verification, implementation and maintenance of software used for monitoring, analyzing and reporting of clinical trials data in support of regulatory submissions and publications.
Responsibilities:
· Adheres to departmental procedures and practices, technical and industry standards and programming concepts and conventions during all aspects of work
· Builds effective working relationships with cross functional groups within BioMetrics, the study team
· Negotiates effectively to meet study objectives
· Leads development and project management of the statistical deliverables planning and design work
· Leads assigned statistical programming team project resources and manages the completion of study statistical programming deliverables to meet project timelines
· Monitors CRO project activities and reviews CRO deliverables as necessary
· Responsible for every aspect of statistical programming deliverables quality
· Conducts program verification, identifies bugs and resolves technical problems
· Assists in the distribution of reports to the project team members
· Investigates trends, identifies techniques and makes recommendations for new methods and technologies used in pharmaceutical and/or biotech industries for reporting and managing clinical data
· Participates in the development of standard reporting tools and system utilities for the statistical programming group
· Contributes to developing BioMetrics SOPs
Experience:
Clinical Trials
· A minimum of six years SAS programming experience in pharmaceutical and/or biotech company
· Thorough knowledge of clinical operations and data management roles
· Thorough knowledge of data collection practices and data flow
· Commanding understanding of the Biometrics role in a clinical trials setting
Statistical Programming
· Advanced knowledge of Base SAS including macro language and proc report
· Intermediate to advanced knowledge of SAS/GRAPH
· Advanced knowledge of SAS/STAT or other statistical software
· University level statistics course(s) or equivalent experience in statistics
· Ability to interpret tabular and graphical clinical data presentations
Computer Systems
· Must possess an understanding of computers at system level with proficiency in UNIX
· Intermediate understanding of scripting desirable
· Intermediate understanding of Internet architecture and web development desirable
· Intermediate knowledge of Oracle Clinical or other clinical data management software is desirable
Desktop
· Intermediate Word, Excel and PowerPoint
· Intermediate Ms Project desirable
Regulatory
· Advanced knowledge of regulatory guidelines and the software development life cycle
· Electronic NDA and/or BLA submissions via eCTD
· Experience responding to FDA/regulatory requests
Project Management
· Capable of independently leading and managing projects
· Capable of working on multiple tasks and shifting priorities
· Motivated and shows initiative
· Detail oriented
Communication
· Capable of well organized, concise and clear written and verbal communication
· Capable of comprehending written specifications and translating them into well documented and clearly structured programs
· Effective at explaining technical concepts to a varied audience in both an individual and group setting
· Effective presentation skills
Education:
Minimum educational experience is a BS in computer science, mathematics, statistics, or related analytic field.
Preferred educational experience is a MS in Statistics/Biostatistics/Biometrics or related field.
Posted 5/19/2008
NAME OF POSITION: Manager, Statistical Programming & Analysis
LOCATION: Novato/Brisbane, California-San Francisco 94949
Position type: Full time
Reports To: Associate Director, SAS Systems and Statistical Programming
Summary
The Manager of Statistical Programming & Analysis has both administrative and functional oversight responsibilities for Statistical Programming & Analysis staff supporting both regulatory submissions and publications.
Responsibilities
· Participates in BioMetrics resource forecasting and budgeting activities
· Develops and leads the Statistical Programmer Analyst recruitment process and participates in broader BioMetrics recruitment activities
· Develops Statistical Programming & Analysis related SOPs and contributes to developing BioMetrics SOPs
· Develops statistical programming guidelines and training curriculum
· Establishes adaptive mentoring and coaching practices for Statistical Programmer Analysts
· Establishes goals for Statistical Programmer Analysts that align with those of the BioMetrics department and the company
· Conducts performance evaluations against established goals
· Builds effective partnerships with cross functional groups within BioMetrics, the study team and across BioMarin to ensure that customer/stakeholder needs are met
· Participates on department special project teams focused on improving business operations and process improvement
· Makes recommendations for implementing new statistical programming methods and technologies for reporting and managing clinical data
· Oversees the completion of all assigned projects by identifying and allocating necessary resources and monitoring project status against objectives and timelines
· Supports staff as necessary to negotiate project timelines
· Accountable for every aspect of statistical programming deliverables quality
· Ensures work adheres to departmental procedures and practices, technical and industry standards and programming concepts and conventions in all areas of execution
· Oversees development and management of the statistical deliverables planning and design work
· Oversees CRO activities and reviews CRO deliverables as necessary
Experience
Management
· Minimum of two years administrative and/or functional management experience as a manager, supervisor or team lead in a clinical development setting
· Demonstrated leadership abilities
· Understanding of budgeting process
· Experience establishing working relationships with and overseeing vendors
· Experience establishing partnerships with cross functional groups in a clinical development setting
· Experience with delegating and overseeing projects and tasks
· Experience with establishing department and/or project level processes/procedures
· Experience coaching/mentoring statistical programmer analysts in both behavioral and technical areas
Clinical Trials
· A minimum of eight years SAS programming experience in pharmaceutical and/or biotech company
· Thorough knowledge of clinical operations and data management roles
· Thorough knowledge of data collection practices and data flow
· Commanding understanding of the Biometrics role in a clinical trials setting
Statistical Programming
· Advanced knowledge of SAS Software including BASE/SAS, SAS/GRAPH and SAS/STAT
· Other statistical software package (S-Plus, StatXact, etc.) knowledge desirable
Computer Systems
· Demonstrated proficiency in UNIX
· Intermediate understanding of scripting desirable
· Intermediate understanding of Internet architecture and web development desirable
· Intermediate knowledge of Oracle Clinical or other clinical data management software is desirable
Desktop
· Intermediate Word, Excel and PowerPoint
· Intermediate Ms Project desirable
Regulatory
· Advanced knowledge of regulatory guidelines and the software development life cycle
· Electronic NDA and/or BLA submissions via eCTD
· Experience responding to FDA/regulatory requests
Project Management
· Capable of managing multiple projects in support of varied customer needs and functions
· Capable of working on multiple tasks and shifting priorities
· Motivated and shows initiative
· Detail oriented
Communication
· Capable of well organized, concise and clear written and verbal communication
· Capable of clear and effective communications across disciplines
· Effective at explaining technical concepts to a varied audience in both an individual and group setting
· Effective presentation skills
Education
Minimum educational experience is a BS in computer science, mathematics, statistics, or related analytic field.
Preferred educational experience is a MS in Statistics/Biostatistics/Biometrics or related field.
Posted 5/19/2008
NAME OF POSITION: Sr. Statistical Programmer Analyst
LOCATION: Novato, CA
JOB ID: 08-0016
To apply for this position: Click on https://www.ultirecruit.com/bio1001/jobboard/JobDetails.aspx?__ID=*5E9885FCB936D890
ABSTRACT OF POSITION:
The Senior Statistical Programmer Analyst applies advanced programming techniques and leads the planning, design, development, verification, implementation and maintenance of software used for monitoring, analyzing and reporting of clinical trials data in support of regulatory submissions and publications.
RESPONSIBILITIES
Adheres to departmental procedures
and practices, technical and industry standards and programming concepts and
conventions during all aspects of work
Leads development and management of the statistical deliverables planning and
design work
Leads statistical programming team project resources and manages the
completion of study statistical programming deliverables to meet project
timelines
Monitors every aspect of statistical programming deliverables quality through
data collection to database lock to distribution of final deliverables
Assists in the distribution of reports to the project team members
Builds effective working relationships with cross functional groups within
Biometrics, the study team and across BioMarin
Negotiates effectively to meet study objectives
Leads or participates in department special project teams focused on
improving business operations and process improvement
Investigates trends, identifies techniques and makes recommendations for new
methods and technologies used in pharmaceutical and/or biotech industries for
reporting and managing clinical data
Develops standard reporting tools and system utilities for the statistical
programming group
Develops Biometrics SOPs
Oversees CRO activities and reviews CRO deliverables as necessary
EDUCATION
Minimum educational experience is a BS
in computer science, mathematics, statistics, or related analytic field.
Preferred educational experience is a MS in Statistics/Biostatistics/Biometrics
or related field.
EXPERIENCE
Clinical Trials
A minimum of 6 years SAS programming experience in pharmaceutical and/or
biotech company
Thorough knowledge of clinical operations and data management roles
Thorough knowledge of data collection practices and data flow
Commanding understanding of the Biometrics role in a clinical trials setting
Statistical Programming
Advanced knowledge of Base SAS including macro language and proc report
Intermediate to advanced knowledge of SAS/GRAPH
Advanced knowledge of SAS/STAT or other statistical software
University level statistics course(s) or equivalent experience in statistics
Ability to interpret tabular and graphical clinical data presentations
Computer Systems
Must possess understanding of computers at system level with proficiency in
UNIX
Intermediate understanding of scripting
Intermediate understanding of Internet architecture and web development
desirable
Intermediate knowledge of Oracle Clinical or other clinical data management
software is desirable
Desktop
Intermediate Word, Excel and PowerPoint
Intermediate Ms Project desirable
Regulatory
Advanced knowledge of regulatory guidelines and the software development life
cycle
Electronic NDA and/or BLA submissions via eCTD
Experience responding to FDA/regulatory requests
Communication
Capable of well organized, concise and clear written and verbal communication
Capable of comprehending written specifications and translating them into
well documented and clearly structured programs
Effective at explaining technical concepts to a varied audience in both an
individual and group setting
Effective presentation skills
Project Management
Capable of independently leading and managing projects
Capable of working on multiple tasks and shifting priorities
Motivated and shows initiative
Detail oriented
Posted 1/22/2008
NAME OF POSITION: Statistical Programmer Analyst III
LOCATION: Novato, CA
JOB ID: 07-0067
To apply for this position: Click on https://www.ultirecruit.com/bio1001/jobboard/JobDetails.aspx?__ID=*CE2D8D6894D82E71
ABSTRACT OF POSITION:
The Statistical Programmer Analyst III applies intermediate to advanced programming techniques and assists in the planning, design, development, verification, implementation and maintenance of software used for monitoring, analyzing and reporting of clinical trials data in support of regulatory submissions and publications.
RESPONSIBILITIES
Adheres to departmental procedures
and practices, technical and industry standards and programming concepts and
conventions during all aspects of work
Collaborates with project lead Statistical Programmer Analyst to develop the
statistical deliverables planning and design work
Completes study statistical programming deliverables to meet project
timelines
Completes program development and documentation of data sets, tables,
listings and graphs
Conducts program verification, identifies bugs and resolves technical
problems
Monitors every aspect of statistical programming deliverables quality through
data collection to database lock to distribution of final deliverables
Assists in the preparation and distribution of reports to the project team
members
Builds effective working relationships with cross functional groups within
Biometrics and the study team
Develops standard reporting tools for the statistical programming group
Participates in developing Biometrics SOPs
Participates in overseeing CRO activities and reviewing CRO deliverables as
necessary
EDUCATION
Minimum educational experience is a BS
in computer science, mathematics, statistics, or related analytic field.
Preferred educational experience is a MS in Statistics/Biostatistics/Biometrics
or related field.
EXPERIENCE
Clinical Trials
A minimum of 4 years SAS programming experience in pharmaceutical and/or
biotech company
Knowledgeable of clinical operations and data management roles
Knowledgeable of data collection practices and data flow
Commanding understanding of the Biometrics role in a clinical trials setting
Statistical Programming
Intermediate to advanced knowledge of Base SAS including macro language and
proc report
Intermediate knowledge of SAS/GRAPH
Intermediate knowledge of SAS/STAT or other statistical software
University level statistics course(s) or equivalent experience in statistics
Ability to interpret tabular and graphical clinical data presentations
Computer Systems
Must possess understanding of computers at system level with proficiency in
UNIX preferred
Basic understanding of scripting
Basic understanding of Internet architecture and web development desirable
Working knowledge of Oracle Clinical or other clinical data management
software is desirable
Desktop
Intermediate Word, Excel and PowerPoint
Basic Ms Project desirable
Regulatory
Intermediate knowledge of regulatory guidelines and the software development
life cycle
Electronic NDA and/or BLA submissions via eCTD preferred
Experience responding to FDA/regulatory requests preferred
Communication
Capable of well organized, concise and clear written and verbal communication
Capable of comprehending written specifications and translating them into
well documented and clearly structured programs
Effective at explaining technical concepts to a varied audience in both an
individual and group setting
Effective presentation skills
Project Management
Capable of leading and independently managing projects
Capable of working on multiple tasks and shifting priorities
Motivated and shows initiative
Detail oriented
Posted 1/15/2008