Pharmapace welcomes qualified and motivated candidates to apply for a variety of positions. We are a fast growing and specialized consulting/outsourcing company (CRO) serving the biotech and pharmaceutical companies in their clinical development programs.  We offer a stimulating working environment and excellent career growth opportunity.

Current Positions Available

(click on position for key responsibilities, qualifications, and skills)

Key responsibilities:

• Assist DSP members with transforming specifications in statistical analyses plan into fully documented, validated programs supporting both safety and efficacy displays and analysis datasets required for clinical study reports
• Independently testing, maintaining and documenting programs for use in creating study datasets in standard data tabulation model format, analysis data sets, statistical tables, figures, and listings
• Assist Clinical Data Management with creating well documented validated standard and non-standard edit check and monitoring programs to support the clinical trial team to ensure the integrity, accuracy and completeness of the data in preparation for clinical reporting
• Adhere to statistical analysis plans and standard operating procedures while completing routine programming activities
• Meet milestones as assigned with high quality
• Perform other duties as directed by management or senior programming personnel

Qualifications and skills:

• Bachelor’s or advanced degree in statistics, biostatistics, computer science or related scientific fields
• 0-2 years of relevant work experience
• Base SAS, SAS/GRAPH, SAS/STAT, and SAS macro language
• SAS programming experience in a research environment
• Credits in statistics courses
• Understands the sequence of running SAS programs to ensure up-to-date data and to troubleshoot, debug SAS programming problems and to identify data trends
• Proficiency in Microsoft Office (Word, Excel and PowerPoint)
• Effective verbal and writing skills

Key responsibilities:

• Creates new programs, troubleshoots and updates programs written by colleagues in support of design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data
• Provides comprehensive programming support for project teams including development of programming strategies, standards, specifications and programmed analysis
• Independently leads and/or performs programming assignments across multiple projects with minimal supervision
• Provides leadership for ensuring quality of deliverables by consistently applying programming standards and complying with regulatory requirements, protocols, guidance and corporate and departmental SOPs and work practices
• Provides statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
• Assists in the development and/or maintenance of departmental procedures and standards
• Reviews key study documents (e.g. CRFs, DMP, SAP, data specifications) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements
• Performs other duties as directed by management or senior programming personnel

Qualifications and skills:

• Bachelor’s or advanced degree in statistics, biostatistics, computer science or related scientific fields
• Minimum 4 years of experience in the pharmaceutical/biotech industry for Bachelor’s and 2 years for Master’s degree
• Advanced knowledge with Base SAS, SAS/GRAPH, SAS/STAT, and SAS macro language
• SAS programming with clinical trial study data
• Advanced knowledge in Statistics
• Advanced knowledge with industry standards, such as the ICH guidelines, CDISC data standards (SDTM and ADaM), 21 CFR Part 11 and FDA guidelines
• Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
• Excellent communication and interpersonal skills to effectively interface with others

Key responsibilities:

• Play leading role in study by managing and overseeing SAS programming activities from different aspects (programming aspect, statistical aspect and clinical trial aspect) to ensure SAS programming activities to follow regulatory and company standards
• Ensure high-efficient, high-quality and timely deliverables with limited oversight
• Contribute to the preparation, execution, reporting and documentation of SAS programming within several therapeutic areas
• Create, manage, and maintain the SAS programming algorithm for the clinical study database and data analysis, and contribute to development and quality control of the clinical and statistical programming deliverables
• Responsible for peer review of the submission packages and contribute to the input of SAP and mock TFLs
• Perform ad hoc analyses with flexible and rapid programming arising from questions generated from planned analyses and results to support Phase I to IV clinical trials and medical publications
• Maintain efficient interfaces with internal and external customers and vendors with support of the collaborating statisticians
• May contribute to the creation and maintenance of company tools or department SOPs related to clinical data analysis
• May mentor junior analysts/programmers

Qualifications and skills:

• Bachelor’s or above degree in statistics/biostatistics or computer sciences
• Minimum 6 years of experience in the pharma/biotech industry for Bachelor’s and 4 years for Master’s or be able to perform the essential job functions
• Advanced SAS programming skills (e.g, SAS SQL, SAS Macro, SAS/STAT, SAS/GRAPH, etc.) with clinical trial data
• Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats
• Advanced clinical trial knowledge preferred, and knowledge of at least one therapeutic area
• Advanced knowledge in industry standards, such as the ICH guidelines, CDISC standards, 21 CFR Part 11, and FDA guidelines
• Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, EDC, eDT, SDTM, and in providing outputs to meet downstream requirements, e.g., ADaM, define.xml and TFLs
• Excellent organizational skills, time management, and ability to lead SAS programming activities, coordinate workload, and meet established deadlines
• Excellent communication and interpersonal skills to effectively interface with others

Key responsibilities:

• Leads all the programming activities including planning, organizing, delegating, coordinating and managing programming activities from start to finish by overseeing all development, validation and production of programs for a set of studies or multiple clients
• Provides technical solutions to a wider range of problems with higher level of complexity
• Independently determines and develops approach to solutions
• Adapts to changing circumstances, policies, work assignments and/or team members
• Creates and maintains complete and up-to-date study documentation in compliance with Pharmapace and regulatory standards
• Tracks projects against goals and submit status reports to project management
• Recommends technical and process solutions that can be used or developed to increase efficiency of project work
• May maintain or develop departmental procedures and standards
• Contributes to the development of department-level standards, tools and templates
• Contributes to user aspects of technical infrastructure or business process initiative with a focus on statistical programming, data process and analysis reporting procedures
• Negotiates effectively within project teams and working groups for reasonable timelines and scope, also negotiates alternative timelines based on resourcing/ priority constraints
• Manages projects independently
• Mentors junior analysts/ programmers
• May supervise junior analysts/ programmers

Qualifications and skills:

• Bachelor’s or advanced degree in statistics, biostatistics, computer science or related fields
• Minimum 8 years of experience in the pharmaceutical/biotech industry for Bachelor’s and 6 years for Master’s degree
• Experience in leading the programming activities for submissions
• Excellent skills in SAS programming
• Excellent clinical trial knowledge is preferred
• Working knowledge of other software such as S-plus and WinNonlin is preferred
• Advanced knowledge in industry standards such as ICH guidelines, CDISC standards, 21 CFR Part 11 and FDA guidelines is required
• Excellent organizational skills, time management and ability to coordinate workload and meet established deadlines
• Excellent communication and interpersonal skills to effectively interface with others

Key responsibilities:

• Lead experience managing at least 3 studies simultaneously
• Responsible for vendor management or third party management
• Will participate in development of budget and timelines for client projects
• Will represent Data Management (DM) function in interactions with clients
• Responsible for CRF development based on protocol review
• Creation and/or review of data management plans, database specifications, edit check specifications and data entry guidelines
• Responsible to work directly with EDC developers in the development of quality and timely Electronic Case Report Forms (eCRFs); EDC system setup including UAT
• Responsible for ongoing data review and query management
• Receipt and archive of clinical trial data and/or data management documentation
• Responsible to coordinate coding for adverse events and concomitant medications
• Perform all DM responsibilities in accordance with company guidelines and Standard Operations Procedures and appropriate industry and regulatory standards and Good Clinical Practices.
• Ensure complete and accurate documentation for all data management activities

Qualifications and skills:

• BA or BS in a life science, computer science, or related fields
• Minimum 7 years of experience in Data Management within the pharmaceutical/biotech industry
• Minimum 3 years in a Lead Data Manager role
• Understanding of current industry standard best data management practices
• Understanding of industry standard regulations and GCPs
• Familiar with the most common standard coding dictionaries and processes
• Strong initiative, excellent interpersonal and communication skills

Key responsibilities:

• Assist with protocol preparation, sample size and power calculations, and randomization schedule generation
• Review case report forms to ensure appropriate data collection
• Review edit checks algorithm to ensure data quality for statistical analyses
• Participate in study team operations and timeline discussion
• Prepare statistical analysis plans and mock tables, figures, and listings
• Review data and programming specifications, and Perform statistical validation/quality control on analyses generated by statistical analysts/programmers
• Conduct inferential statistical analyses and check model adequacy of statistical analyses
• Write/Review statistical sections of study reports
• Participate in clinical results interpretation meetings
• Work with medical writers to assist with clinical study reports preparation
• Work with project managers to ensure timely and high quality delivery of analysis packages

Qualifications and skills:

• MS or Ph.D. degree in statistics, biostatistics, mathematics, or epidemiology
• 0-2 years of relevant work experience
• Excellent understanding of statistical concepts and methods
• Experience with statistical programming with SAS for clinical studies is required
• Highly motivated.  Good interpersonal and communication skills

Key responsibilities:

• Provide input to clinical study design and protocol preparation.
• Perform power and sample size calculation.
• Generate randomization schedule.
• Author statistical analysis plan and provide statistical interpretation for study report preparation.
• Conduct inferential statistical analyses.
• Identify and resolve statistical issues.
• Write/Review statistical sections of study reports
• Participate in clinical results interpretation meetings
• Work with medical writers to assist with clinical study reports preparation
• Work with project managers to ensure timely and high quality delivery of analysis packages

Qualifications and skills:

• PhD degree in statistics/biostatistics with 2+ years or MS degree with 4+ years of experience in the pharmaceutical/biotech industry or life science research
• Experience with statistical programming with SAS for clinical studies is required
• Highly motivated.  Good interpersonal and communication skills

Key responsibilities:

• Provide input to clinical study design and protocol preparation, including power and sample size calculation
• Prepare statistical analysis plans and provide statistical interpretation for study report preparation
• Conduct inferential statistical analyses.
• Identify and resolve statistical issues.
• Research and stay current with innovated statistical methodologies
• Advise clients in drug approval and submission process and interact with regulatory agencies
• Supervise and mentor junior statisticians

Qualifications and skills:

• PhD degree in statistics/biostatistics with 5+ years or MS degree with 7+ years of experience in the pharmaceutical/biotech industry or life science research
• Experience with SAS statistical programming for clinical studies is required
• Highly motivated.  Good interpersonal and communication skills

Key responsibilities:

• Deploy and configure IT system hardware and related infrastructure and software applications, ensure proper configuration inline with IT guidelines including active directory, group policy, exchange, and firewalls.
• Construct and manage networks using TCP/IP, VLANs, subnets, DNS, DHCP, VPN, and network security technologies.
• Manage and maintain the system virtualization using Hyper-V and VMware.
• Create SAS server, install and configure SAS software.
• Plan, implement and review the Computer System Validation following GAMP5 guideline, including the execution of IQ/OQ/PQ testing, to make sure the computer-based GxP software/system operates as intended and meet 21 CFR Part 11 requirements.
• Develop and implement data security policies and disaster recovery plans; Perform patch management and maintenance of all IT systems.

Qualifications and skills:

• Must have a Master’s Degree in Computer Science, Computer Engineering, or Electrical Engineering plus 1 year experience in job offered.
• Require skills and knowledge in Active Directory, Hyper-V, Exchange, SAS, 21 CFR Part 11, GAMP5.

Job location: San Diego, CA. This position is eligible for Employee Referral Program. Send résumé with job code YIC001 to HR, Pharmapace Inc., 10509 Vista Sorrento Pkwy, San Diego, CA 92121

DUTIES:

• Lead programming activities for clinical studies.
• Provide extensive technical expertise as part of the Database and Statistical Programming (DSP) team to develop, test, maintain, validate, and document programs to meet business needs.
• Work within general programming standards and procedures to independently conduct statistical programming projects.
• Provide support to the development of project-related solutions to the full scope of database and statistical programming tasks.
• Play leading role in study by managing and overseeing SAS programming activities from different aspects (programming aspect, statistical aspect and clinical trial aspect) to ensure SAS programming activities to follow regulatory and company standards.
• Ensure high-efficient, high-quality and timely deliverables with limited oversight.
• Contribute to the preparation, execution, reporting and documentation of SAS programming within several therapeutic areas.
• Create, manage, and maintain the SAS programming algorithm for the clinical study database and data analysis, and contribute to development and quality control of the clinical and statistical programming deliverables.
• Responsible for peer review of the submission packages and contribute to the input of SAP and mock TFLs.
• Perform ad hoc analyses with flexible and rapid programming arising from questions generated from planned analyses and results to support Phase I to IV clinical trials and medical publications.
• Maintain efficient interfaces with internal and external customers and vendors with support of the collaborating statisticians.
• May contribute to the creation and maintenance of company tools or department SOPs related to clinical data analysis.
• May mentor junior analysts/programmers.

REQUIREMENTS:

• Will accept a Master’s degreeor or foreign academic equivalent in Statistic, Biostatistics, Computer Science, Project Management, or related field and three (3) years of experience in a related occupation.
• Will also accept a Bachelor’s degree or foreign academic equivalent in Statistic, Biostatistics, Computer Science, Project Management or related field and five (5) years of progressive experience in a related occupation.
• Employer will accept any suitable combination of education, training or experience.

OTHER:

Job Site: 10509 Vista Sorrento Parkway, Ste 303, San Diego, CA
40 hours/week; $104,042.00/year
EEO employer: including race, gender, disability & veteran status.

Contact:

To apply, mail resume w/ ref# to:
Pharmapace, Inc.
Attn: Jennifer Cassidy;
10509 Vista Sorrento Parkway, Ste 303, San Diego, CA 92121 EEO

Reference Number: CL-CA

This notice is being provided as a result of the filing of a permanent alien labor certification application for this job opportunity. Any person may provide documentary evidence bearing on the application to:
U.S. Department of Labor
Employment and Training Administration Harris Tower
233 Peachtree Street, Suite 410 Atlanta, GA 30303