Gilead Sciences is currently seeking a Manager of Biostatistics

Senior Statistical Programmer – Biometrics, Foster City

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, we seek to improve the care of patients suffering from life-threatening diseases.

Gilead’s primary areas of focus include HIV/AIDS, liver disease and serious cardiovascular and respiratory conditions.

Our portfolio of 13 marketed products includes a number of category firsts and market leaders, including Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) – the first single-tablet regimen for HIV infection. Viread® (tenofovir disoproxil fumarate), the company’s first agent approved for HIV infection, was also approved in 2008 for the treatment of chronic hepatitis B. Chronic hepatitis B, a serious liver disease caused by the hepatitis B virus, is the leading cause of liver cancer worldwide and affects an estimated two million individuals in the United States. Most recently, Cayston® (aztreonam for inhalation solution) was granted approval in February 2010 to be used to improve respiratory symptoms in cystic fibrosis patients.

Specific Responsibilities:

Works collaboratively with Biostatisticians, Statistical Programmers, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting.

Essential Duties and Job Functions:

Identifies potential issues in statistical analysis plans and proposes solutions.

Assesses the quality of analysis data and performs cross-study analyses.

Uses internal macros or writes SAS® macros to automate statistical table, figure, and listing production.

Assists in the preparation of submissions of electronic data (e.g., SAS® data sets) to regulatory agencies.

Independently develops analysis file programs.

Works as a primary programmer for multiple Phase 1-3 studies and as a secondary programming contact for one or more Phase 1-3 studies.

Contributes to strategic initiatives.

Excellent verbal and written communication skills and interpersonal skills are required.
Has thorough knowledge of clinical trial study design and electronic data submission requirements.

Must be able to work independently on multiple concurrent projects.

Must be capable of attending study team meetings as the primary statistical programming contact.

Knowledge, Experience and Skills:

4+ years of experience and a BS degree in Biostatistics or Computer Science.

2+ years of experience and a MS degree in Biostatistics or Computer Science.

1+ years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent.

To apply, please submit resume through our website at https://www.gilead.apply2jobs.com/index.cfm?fuseaction=mExternal.showJob&RID=4820&CurrentPage=1 . Gilead is an equal opportunity employer.

Statistical Programmer II, Biometrics, Foster City

Gilead’s primary areas of focus include HIV/AIDS, liver disease and serious cardiovascular and respiratory conditions.

Specific Responsibilities:

Primary responsibilities include: assesses the quality of analysis data, performs cross-study analyses, uses internal macros to automate statistical table, figure, and listing production; assists in submissions of electronic data (e.g., SAS® data sets) to regulatory agencies, creates MS PowerPoint graphs and in-text tables. Works as a secondary programming contact for two Phase 1-3 studies.

Essential Duties and Job Functions:

Knowledge, Experience and Skills:

Typically requires a BS degree in Biostatistics/Computer Science or equivalent and minimum 3 years of experience in the occupation or as a Programmer/Analyst, or a MS degree in Biostatistics/Computer Science or equivalent and minimum 1 years experience in the occupation or as a Programmer/Analyst. Must have work experience in the statistical analysis of biomedical data using SAS® software, or be certified in the following areas of SAS programming; accessing data, creating data structures, managing data, and generating reports.

To apply, please submit resume through our website at https://www.gilead.apply2jobs.com/index.cfm?fuseaction=mExternal.showJob&RID=4604&CurrentPage=1 . Gilead is an equal opportunity employer.

Clinical Programmer II, Foster City

Gilead’s primary areas of focus include HIV/AIDS, liver disease and serious cardiovascular and respiratory conditions.

Specific Responsibilities:

The Clinical Programmer is housed within the Biometrics department working closely with Data Management, Biostatistics, Clinical Research and other clinical programmers. Primary responsibility is to work effectively with several groups to coordinate study activities, and to communicate EDC issues with internal management and EDC vendor.

Key duties include:

· Oversee creation and validation of edit check specifications

· Construct electronic edit checks based on specifications

· Create and validate user requirements documents for various system modules

· Create and validate report listings and datasets for clinical and data management review, as well as regulatory submissions

· Assist with database output creation and validation

· Ensure database accuracy and implement database validation in compliance with SOPs

· Review and adhere to departmental SOPs

· Maintain study documentation in compliance with SOPs

Qualifications:

- Bachelor degree in computer science, biomedical science or other related discipline

- 2-3 years minimum experience working in clinical trials is required

- Must be familiar with SAS programming, Relational Database concepts, EDC systems, and Data Management processes from study start-up through submission

- Requires strong organizational and interpersonal skills

- Must have the ability to multitask, prioritize and troubleshoot issues

- Proven track record of achieving results

Essential Duties and Work Functions:

Works collaboratively within Biometrics assisting in providing support to Clinical Data Management activities. Works with lead Clinical Programmer to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. Ensures completeness, correctness and consistency of basic clinical data and data structure. Provides timely support to the study team on all programming matters according to the project plan and programming specification using well-defined internal standards and guidelines. Provides input to CRF/eCRF reviews and edits checks Contributes to the reporting of basic clinical data. Supports through regulatory approval, product launch and annual reports; contributing to the monitoring of data quality during study conduct.

Knowledge, Experience and Skills

Typically requires a BS degree in a Biomedical Science or equivalent and minimum 2 years of relevant experience along with clinical background/experience and SAS programming in a CRO or bio/ pharmaceutical setting, or a MS degree and minimum 1 year of relevant experience. Excellent verbal and written communication skills and interpersonal skills are required. Knowledge of pharmaceutical clinical development and ability to provide programming supports needs for NDA and other regulatory submissions. Understanding of statistical concepts and techniques and of clinical trial principles is required.

To apply, please submit resume through our website at https://www.gilead.apply2jobs.com/index.cfm?fuseaction=mExternal.showJob&RID=4575&CurrentPage=1. Gilead is an equal opportunity employer.

Manager, Clinical Programming (EDC), Foster City

Gilead’s primary areas of focus include HIV/AIDS, liver disease and serious cardiovascular and respiratory conditions.

Specific Responsibilities:

Manager will work with Biometrics and Clinical personnel to develop and implement best practice processes related to EDC system configuration, study design and development. Manager will also work with EDC vendor on knowledge transfer processes and will be primarily responsible for all internal production EDC programming activities supporting all therapeutic areas. Successful candidate will be a strong team leader, mentoring direct reports, while also acting as individual contributor on study related work. Good knowledge of industry standards and programming practices, with solid EDC programming experience,is required. Experience with other programming languages (e.g. SAS, C#, Perl, SQL), and databases (e.g. Oracle, MS Access, SQL Server) is preferred.

Essential Duties and Job Functions:

Responsible for managing a highly effective team of EDC Programmers supporting moderately complex clinical data management. Work collaboratively with Clinical Data Associate, Statistical Programmer, Biostatistician and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. Ensures completeness, correctness and consistency of moderately complex clinical data and data structure. Provides leadership in the area of systems, processes and tools for clinical data collection and management. Designs and uses all available vehicles for effective scientific communication within and outside the company. Anticipates moderately complex obstacles and difficulties of clients and acts upon demands in order to meet team goals. Participates on departmental management team and provides strategic direction for clinical programming. Considers the implications of conducting international studies, and leads moderately complex initiatives to gather, organize, and analyze interim clinical data from various sources. Examines issues from various perspectives as well as determines and applies appropriate clinical programming concepts when addressing clinical programming solutions.

Knowledge, Experience and Skills:

Typically requires a BS degree in a Biomedical Science or equivalent and minimum 6 years of relevant experience or a MS degree and minimum 4 years of relevant industry experience. Previous management experience is preferred. Experience in EDC programming in a CRO or bio/pharmaceutical setting is required. Excellent verbal and written communication skills and interpersonal skills are required. Working knowledge of pharmaceutical clinical development and the ability to provide programming support needs for NDA and other regulatory submissions is required . Working understanding of statistical concepts and techniques and of clinical trial principles is expected. Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission is required as is the ability to ensure clinical programming work is completed in a consistent manner and validated according to department practices.

To apply, please submit resume through our website at https://www.gilead.apply2jobs.com/index.cfm?fuseaction=mExternal.showJob&RID=4467&CurrentPage=1 . Gilead is an equal opportunity employer.

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