Associate Principal Scientist, Statistical Programming Full-time

Statistical Programming Lead

Lead the statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development projects.

Develop and execute 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.

Design and maintain statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.

Act as a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables.

Serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle for the assigned projects. Assure deliverable quality and process compliance.

Responsible for effective deliverable development utilizing global and TA standards that optimize analysis and reporting and promote a strategic knowledge-base data model.

Maintain and manage a project plan including resource forecasting. Coordinate the activities of a global programming team that includes outsource provider staff.

Serve as a member on departmental strategic initiative project teams such as new statistical computing platform evaluation and development.

Education requirements:

• Must have a Bachelor's degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Biological Sciences, Engineering or closely related field plus 9 years SAS programming experience in a clinical trial environment
• OR a Master's degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Biological Sciences, Engineering or closely related field plus 7 years SAS programming experience in a clinical trial environment.

Requirements:

• Experience and knowledge in leading large and/or complex statistical programming projects that include coordinating the activities of a programming team.
• Experience in CDISC and ADaM standards and demonstrated success in the assurance of deliverable quality and process compliance also required.
• Must possess broad knowledge and significant experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements.
• Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH and systems and database expertise;
• US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables.
• Must possess ability to determine appropriate programming methodology, assure programming consistency across protocols and projects, complete programming tasks, and direct the program development effort of other programmers
• Ability to engage key stakeholders;
• Ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed; Understanding of statistical terminology and concepts; design and develop complex programming algorithms.
• Ability to anticipate stakeholder and regulatory requirements.
• Must be an experienced programming mentor; and a program leader.
• Must possess familiarity with statistical analysis methods and clinical data management concepts; strong project management skills;
• Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilate to new projects and stakeholders.
• Must possess strategic thinking – ability to turn strategy into tactical activities; ability to design statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices.

The salary range for this role is $139,600.00 to $219,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.