Sr. Principal Analyst, Statistical Programming

Role Summary

Leads major statistical programming efforts for clinical program area of responsibility. Develops and recommends system capabilities roadmap for in-house development and external vendor selection process. Acts as a system expert in designing, developing, testing, maintaining, validating, and documenting SAS programs to evaluate clinical data and meet the project requirements for SAS statistical programming efforts. Provides expert-level technical advice for all aspects of the program development process, tools and software, standards and procedures.

Responsibilities

• Provides expert technical leadership across multiple functions serving as the key representative for Biometrics
• Contributes to the development of Biometrics functional strategy and serves as system expert for Statistical Programming efforts
• Leads and mentors a team of statistical programmers to support the analysis and reporting of data from clinical and nonclinical studies for all corporate development programs
• Leads end-to-end statistical programming work-streams on multidisciplinary program teams company-wide
• Provides technical direction in the development and implementation of programming standards and conventions, building statistical programming infrastructure
• Provides workforce planning recommendations based on project workloads in order to ensure appropriate programming resources are available to complete tasks in a timely manner
• Manages vendor selection processes and validates vendor programming activities such as CDISC implementation, analysis reporting, and programming conventions
• Supports creation and validation of e-submission requirements (i.e. annotated CRF, datasets files, define documents)
• Serves as primary/lead programmer for agency reporting deliverables such as DSUR/Annual Report and IB updates
• Performs the function of lead and/or quality control statistical programmer on projects as needed
• Performs other duties as assigned

Qualifications

• BS/BA degree in computer science, mathematics, statistics, or related discipline AND 8+ years in the Biopharmaceutical (or CRO) industry as a statistical programmer with advanced knowledge of SAS, (Base, Stat, Macro, graph), CDISC data structures. In addition, must have at least 2 years of experience serving in a supervisory or lead capacity. Experience managing large projects and external vendors. OR
• Master’s degree in computer science, mathematics, statistics, or related discipline AND 6+ years similar experience noted above OR
• PhD degree in computer science, mathematics, statistics, or related discipline AND 4+ years similar experience noted above
• Anticipates business and industry issues; recommends relevant process / technical / service improvements
• Demonstrates broad expertise or unique knowledge
• Considered an expert within the company and may have external presence in area of expertise
• Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team
• Ability to work as part of and lead multiple teams
• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
• Excellent computer skills
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture and longer-term impact on division/company
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management, strong project leadership skills
• Expert knowledge of the following:
• Developing and implementing statistical programming SOPs and processes in a clinical environment
• Relational databases and complex data systems
• Industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
• Programming skills in SAS, (Base, Stat, Macro, graph), R, STAT or similar
• SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains
• Knowledge of all aspects of writing, validating, and documenting statistical programs, and of creating integrated programming libraries and systems
• Proven experience in multi-discipline, cross-functional project management in a clinical, highly regulated environment
• Track record of success with effectively organizing and managing multiple assignments with challenging timelines across multiple personnel