Lead projects independently from compound level

Education and Minimum Requirement :
BA/BS + 9-12 or MS + 7 or more
years SAS programming experience in a clinical trial environment；

Responsibilities
1. Development and execution of statistical
analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of
which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.
2. Design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.
3. A key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables.
4. For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle.

Required Skills and Experience
- Excellent interpersonal skills and ability to negotiate and collaborate effectively
- Excellent written, oral, and presentation skills
- Broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
- Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders
- Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise
- Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team
- US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables
- Designs and develops complex programming algorithms
- Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts
- Familiarity with clinical data management concepts
- Experience in CDISC and ADaM standards
- Demonstrated success in the assurance of deliverable quality and process compliance
- Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices
- Ability to anticipate stakeholder requirements