Senior / Principal Statistical Programmer (QA/QC) at Vertex Pharmaceuticals
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com.
The Principal Programmer, Statistical Programming (SP) Quality Assurance/Quality Check (QA/QC) works with the SP Management Team to define responsibility for the oversight and operation of QA/QC within the Biometrics Department. The Principal will lead the SP QA/QC activities, working with other Biometrics teams to ensure the accuracy and integrity of clinical trial results that are produced and primarily intended for submission to Regulatory Authorities or Data Monitoring Committees.
- Leads Statistical Programming activities for QA/QC projects by providing expert guidance and direction regarding specific objectives and operational tasks to support timely, targeted, and accurate reporting and outcomes. These activities can range from programming in parallel with a team involved in a pivotal Phase III trial, re-creating in-licensed analysis, helping team’s determine the appropriate level of QC/QA, etc.
- Evaluates Biometrics documents and deliverables for clinical accuracy, internal consistency, external validity, and overall general completeness; confirms adherence to relevant departmental processes, company policies, and ICH guidelines (i.e., GCP).
- Designs SP QA/QC tasks based on the purpose and importance of the deliverable; maintains awareness of overall project timelines to efficiently produce high-quality outputs.
- Contributes to the development of department-level standards, tools, and templates which directly support SP QA/QC objectives.
- Proactively solves complex problems within their specialty area; identifies opportunities for potential process improvement.
- Negotiates effectively within project teams and working groups for reasonable timelines and targeted scope of work.
- Contributes strategies that allow multi-tasking or efficient implementation to reduce execution time to meet deadlines in a fast-paced environment.
- Minimum Requirements;
- M.S./B.S. degree and 10+ years of statistical programming work experience in pharmaceutical companies or CRO.
- Preferred Requirements:
- Good leadership, interpersonal, and negotiation skills to complete deliverables by working effectively with others internally and externally.
- Willingness to proactively partner and collaborate with others on the team in inter-functional settings.
- Good verbal and written communication skills along with effective business presentation skills.
- Sound project management skills, to prioritize multiple tasks and goals to ensure the timely, on-target, and within-budget accomplishment of deliverables.
- Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and effectiveness.
- Demonstrates outstanding attention to detail to ensure accuracy and reliability of results; builds and monitors quality in every work activity.
- Demonstrates outstanding diligence and highly-developed organizational leadership qualities.
- Has a proven ability to plan and allocate time; adapts to changing circumstances, policies, work assignments, and/or team members.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.