Associate Director of Stats Programming

OVERALL RESPONSIBILITIES:

The Programming Leader will lead a team of SAS and R programmers in the Medical Devices Sector. This individual will be accountable for the programming of statistical deliverables for pre- and post-market global clinical trials across all Franchises. S/he ensures that programmed datasets, tables, reports and listings are accurate, while meeting timelines and budgets.

POSITION DUTIES & RESPONSIBILITIES:

Reporting to the Sr. Director, Biostatistics and Data Management, this individual will;

• Provide leadership and direction for Programming by establishing programming standards, and mentoring and managing staff
• Implement and maintain SAS and R platforms that will allow efficient allocation of programming resources
• Develop and maintain global SAS macro and R function libraries.
• Work with Data Management leadership to provide input on data and process standards
• Provide oversight of all programming deliverables for clinical trials
• Develop and maintain global harmonized processes and procedures for programming
• Lead vendor evaluation, selection, contracting, and oversight activities for studies where programming is outsourced to a CRO
• Work with Clinical Data Science partners, and leadership in Clinical Operations and Franchise to set priorities and develop project management plans for trial execution including timelines, milestones, and budgets
• Provide oversight of the quality review of all programming deliverables
• Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times
• Diligently participate in compliance program-related activities as denoted by the supervisor or Chief Compliance Officer
• Performs other related duties as required.

_Functional and Technical Competencies_****:

• Demonstrated ability to lead teams to deliver critical milestones.
• Strong proficiency in Base SAS, SAS/STAT and SAS Macro language. Advanced SAS certification preferred.
• Strong proficiency in R, advanced R programming preferred.
• Experience with CDISC datasets, tables, listings and figures preferred;
• Excellent verbal and written communication skills

_Leadership Competencies_****:

• Connect - Develop strategic partnerships with key internal stakeholders and external experts to lead implementation of industry programming standards
• Shape – Develop knowledge of therapeutic areas within the Franchises and adapt ADaM and STDM standards for medical devices for use in the MD sector
• Lead – build and develop talent through change to provide high quality programming capability
• Deliver – ensure high quality programming deliverables for clinical programs are delivered on time, within budget and in compliance to regulations and SOPs, seamlessly across all Franchises

EDUCATION & EXPERIENCE REQUIREMENTS:

A Bachelor’s degree in Statistics, Computer Science or related discipline, with at least 8 years of programming experience in clinical research within Medical Device or Pharmaceuticals, and at least 3 years of supervisory experience.