Director, Statistical Programming

Responsibilities

• Serve as a lead programmer and provide hands-on programming support for various clinical studies to enable cross-functional teams make timely data driven decisions, internal / external data presentations and regulatory submissions.
• Develop specifications to produce submission ready data packages while ensuring compliance to CDISC and regulatory guidelines.
• Support development and review of study documents including protocols, statistical analysis plans and those supporting database design and data collection.
• Provide guidance and training for onboarding new hires and improving team’s compliance to established guidelines, standards, and procedures.
• Develop or evaluate software tools / utilities and procedures to improve programming efficiency, quality, and cross-functional collaboration.
• Participate and lead organizational initiatives contributing towards improvements in business processes, standardization efforts and implementation of best practices.
• Stay current with industry trends, guidelines, and improvements in technology.
• Perform other duties as assigned.

Qualifications

• BS required; MS preferred in Statistics, Mathematics, or other relevant Scientific Disciplines.
• Minimum 10 years Pharmaceutical/Biotech programming experience including macro/tools development experience.
• FDA submission experience is highly desirable.
• Strong SAS programming and Statistical background with strong skills in SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
• Ability to multitask and apply necessary skills to achieve set goals and objectives in creative and effective ways.
• Solid knowledge CDISC standards (SDTM & ADaM).
• Proficiency in using R, SpotFire, R Shiny, Python etc. is a plus. 
• Experience in supporting oncology studies is a plus.

The base salary hiring range for this position is expected to be $138,600 to $187,300 annually. The base salary offered is negotiable and potentially exceeds the hiring range depending on factors such as the candidate’s relevant knowledge, skills, training, certifications and industry-based experience for the role. Our total rewards package also includes the opportunity for merit-based salary increases, short and long-term incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances. Our robust time-off policy includes accrual of 15 vacation days in first year, 13 paid holidays plus additional time off for a shut-down period during the last week of December, access to sick time, tuition reimbursement and our recognition program.