Senior Principal/TA Technical Lead Statistical Programmer - Wyeth Pharmaceuticals

Location: Cambridge, MA
Categories: Pharmaceutical
Website: https://wyeth.recruitmax.com/MAIN/careerportal/Job_Profile.cfm?szOrderID=21840&szReturnToSearch=1&szWordsToHighlight

Position 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.

Job Summary

Dedicated to a specific therapeutic area, the incumbent represents GBP and is responsible for the requirements collection and definition of GBP application lifecycle. Collaborating with CR&D clinical teams, incumbent collects, analyzes and defines and documents reporting requirements for clinical project/study for both efficacy and safety data. As the author of SAP Part B – Clinical Data Presentation Plan (CDPP), incumbent provides reporting requirements by conforming Wyeth SOP/SPI and standardized data/processes in general, and defines any project/study specifics in particular to ensure the defined reporting requirements meet CSR preparation needs.

The incumbent gets involved in technology assessment and process improvement opportunities. AS needed, the incumbent is selected to be the Lead of submission taskforce to physically implement submission-ready clinical reports.

Additionally, the incumbent provides high-level Wyeth technology and process training to staff. Assists Head of SR&P to coach, mentor and educate staff to maintain a comprehensive and detailed understanding of regulatory reporting requirements and emerging trends in general, and Wyeth standardized processes in particular. As a principal TATL, the incumbent leads submission taskforce and/or technological advancement project or a process improvement project, as required.

Job Responsibilities

Strategic Project Leadership
Leads to develop project plans for complex multi-technology, cross-functional projects, collaborates the activities of project team and for key improvement project. Monitors and reports on project progress to management.

Drug Project Leadership and Client Relationship Management
Leads taskforce or assists the Lead to develop and carry out the project plans for implementing reporting for complex-scale projects, participates actively the activities of the taskforce for Wyeth regulatory submission activities. Monitors and reports on project progress to management.

Builds close working relationships with clinical teams, GBP Implementation Manager, project Biostatisticians and taskforce leaders. Understands business processes and procedures and suggests automation and integration opportunities from TA level perspective as appropriate.

Analysis
Collaborates actively and directly with clinical team members for a specific therapeutic area (TA) to define and prioritize TA’s planned project reporting needs. Analyzes to ensure the overall reporting requirements are in line with Wyeth standards/practices. Specifies any project/study specifics. Authors reporting requirements in SAP-B for implementation. Reviews and finalizes requirements (SAP Part B – CDPP) with Implementation Manage/Taskforce Lead for execution.

Programming
Provides hands-on programming support for TA-specific ad-hoc and post-hoc data processing, reporting and graphical needs other than as CDPP defined.

Maintenance
Defines, documents and track any ad-hoc and post-hoc requirements or any amendment to the finalized CDPP.

Education and Training
Maintains an awareness of Clinical Systems and technology both within the scientific literature and industry. Continues education and training through the utilization of in-house resources, information sharing with colleagues, and attending workshops, seminars, and conferences.
Assists to train staff internally and clinical team members.

Process Adherence and Continuous Improvement
Adheres to all Wyeth / CR&D and GBP processes and procedures but proactively evaluate these processes and recommend improvements.
Understands comprehensively Wyeth CR&D DLP library, data collection standards and reporting technology and make suggestions at high level to further strengthen CR&D data review/reporting processes.

Basic Qualifications

Bachelors’ degree or Masters’ degree or Ph.D. degree of formal education in Statistics, Mathematics, Computer Information Systems or related quantitative sciences is required.

Programming skills in SAS, SQL languages with a sound understanding of clinical data management systems, relational databases, and mainframe/ PC application.
Understanding of the drug development process in the pharmaceutical industry.
Knowledge and relationship 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.
Being able to translate conceptual requirement to defined physical document.
High level of diplomacy

Exposure to at least one high level language (SAS, SQL) in a multi-server computing environment, database management systems, statistical software, or graphics package. Problem solving skills and ability to reason quantitatively and abstractly. Effective verbal and written communications skills. Prior exposure to research environment and knowledge of programming activities would be of added value.

Experience of training others, project management and team leadership.
BA/BS plus 8 to 9 years experience specified above.
MA/MS plus 6 to 7 years experience specified above.
Ph.D. plus 1 to 2 years experience specified above.

How to Apply

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: "21840" 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 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 please visit us at: www.wyeth.com/careers. Wyeth is an Equal Opportunity Employer, M/F/D/V.