Senior Statistical Programmer II - Pharma Clinical

Job Description: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.Senior Statistical Programmer II - clinical trialsWyeth PharmaceuticalsCambridge, Massachusetts (Boston, MA)Requisition 21382Job SummaryProvide statistical programming 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.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 Leads (TALT) to ensure the defined project reporting requirements are physically implemented effectively with the highest quality.Hands-on training of junior staff and contractors and guiding and reviewing the various programming activities of junior level programmer and contractors is likely.Job ResponsibilitiesStrategic 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 and 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: training technical approaches, analysis, project management, new technologies, etc.Basic Qualifications*At least a Bachelors’ Degree is required, preferably with a Statistics, Mathematics, Computer Information Systems, or related quantitative sciences, major.*At least 6 years of relevant experience with a Bachelors, or at least 4 years of relevant experience, or at least some relevant experience with a PhD. Relevant experience includes prior work experience with statistical programming for clinical trials in, or with (Clinical Research Organization - CRO, consulting), a regulated research and development environment, e.g., pharmaceuticals, biopharmaceuticals, medical device.*A sound understanding of the drug development process, clinical data management systems, and clinical trial regulations and submissions including the relationship of the core drug development disciplines (Data Management, Biostatistics, Clinical Writing, Medical Monitoring, and Information Systems) is desired.*Solid interpersonal and teamwork skills, effective communication skills - written and verbal, organization and attention to detail is required.*Training experience and presentation skills and project management methodology is preferred. If you are not viewing this from our career web site, go to https://wyeth.recruitmax.com/main/careerportal/login.cfm, click on the ''Job Search'' tab, use Keywords: ''21382'' for a search, click on the ''Job Title'' link and then ''Apply To This Job'' at the end of the page. If you are unsure whether or not you already have a candidate profile in our database, request your forgotten password before attempting to create a new one. Please make sure that you have both a text version of your resume in the appropriate field as well a Word version attached to your profile.Relocation is not available for this position.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. Search Firm Representatives please read the following carefully: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.Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.Job Experience:See above.Expected Travel Time: None       www.wyeth.com/careers Wyeth is an equal opportunity employer that shares the vision of a diverse workplace. Search Firm Representatives: Please Read Carefully. 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.Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.