Wyeth Pharmaceuticals, Clinical Statistical Programming opportunities

From sasCommunity

Statistical Programmers for clinical R&D (**seniority/title will be dependant upon the level of education and experience) Department Name: Global Biostatistics and Programming (GBP) Location: Collegeville, Pennsylvania (Philadelphia, PA), Cambridge, Massachusetts (Boston, MA) and/or Pearl River, New York (New York, NY)

Job Summary

Provide statistical reporting and reporting support for Clinical R&D projects as part of a taskforce for Wyeth worldwide submissions. Analyze requirements to design, develop, validate, maintain and document structured programs and systems for clinical reporting applications using appropriate Wyeth technologies by conforming Wyeth SOP/SPI and standardized processes.

Provide hands-on training to junior staff or contractors, guiding and reviewing the various programming activities of junior level programmer and contractors. Involvement in technology assessment and process improvement opportunities should be expected and/or as a Lead for collaborating interactively with Global Biostatistics and Programming Therapeutic Technical Lead (TALT) to ensure the defined project reporting requirements are physically implemented effectively with the highest quality.

Job Responsibilities

• Strategic Project Leadership:

Lead or involve to develop project plans for complex multi-technology, cross functional projects, direct the activities of project team for key improvement project. Monitor and report on project progress to management.

• Drug Project and Taskforce Leadership:

Lead taskforce or assist Lead to develop project plans for complex-scale projects, direct the activities of the taskforce for Wyeth regulatory submission activities. Monitor and report on project progress to management.

• Analysis:

Work with TA Technical Lead (TATL) and Implementation Manager (IM) directly and with clients indirectly to define their business requirements in preparation for developing program solutions. Review and finalize reporting requirements (SAP Section B - CDPP) defined by TATL in preparation for programming. Involve with Data Reporting Verification (DRV) process to analyze abnormal data issues. Proactively recommend opportunities for improvement.

• Programming:

Design and develop the simple- to intermediate- level components of systems, particularly integration code, etc. to meet the functional requirements. Particular emphasis on integrating various technologies to create a total solution. Perform testing and validation. Output is used in global regulatory submissions, IND reporting efforts, and alliance partner agreements.

• Maintenance:

Address problems or questions related to production applications. Analyze problems, implement solutions and document activities.

• Education and Training:

Maintain an awareness of Clinical Systems and technology both within the scientific literature and industry. Continue education and training through the utilization of in-house resources, information sharing with colleagues, and attending workshops, seminars, and conferences.

• Process Adherence and Continuous Improvement:

Adhere to all Wyeth / CR&D and GBP processes and procedures but proactively evaluate these processes and recommend improvements.

• External client collaborating and internal coaching and mentoring:

Build close working relationships with submission teams. Understand business processes and procedures and suggest automation and integration opportunities as appropriate. Coach and mentor junior level staff in technical approaches, analysis, project management, new technologies, and client.

Basic Qualifications

• Bachelors Degree (a Statistics, Mathematics, Computer Information Systems or related quantitative sciences major is preferred).
• Relevant work experience of at least 4 years with a Bachelors, 1 year with a Masters or a Doctorate with some clinical statistical work. **Senior and Principal Statistical Programmer level positions require additional amounts of relevant work experience.
• Clinical programming, statistical programming, SAS programming skills in the pharmaceutical industry as an employee, working for CRO or as a consultant.
• Understanding of the drug development process in the pharmaceutical industry and a knowledge of the core disciplines (Data Management, Biostatistics, Clinical Writing, Medical Monitoring, and Information Systems) in a drug development environment.
• Solid interpersonal and teamwork skills, including effective writing and verbal communication, attention to detail and organization.
• Training and presentation skills.
• Project management methodology.

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Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs.

For more information and to apply online, please visit us at: www.wyeth.com/careers.

Wyeth is an Equal Opportunity Employer, M/F/D/V.

At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business.

Search Firm Representatives: Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void.