Sr. Principal Analyst, Statistical Programming

About the role

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.

Responsibilities

• Provides expert technical leadership across multiple functions serving as the key representative for Biometrics.
• 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.
• Manages vendor selection processes and validates vendor programming activities such as CDISC implementation, analysis reporting, and programming conventions.
• 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.

Requirements

• 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.
• 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.
• Desired: Demonstrates broad expertise or unique knowledge, considered an expert within the company and may have external presence in area of expertise.
• Desired: Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team.
• Desired: Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams.
• Desired: Excellent computer skills, excellent communications, problem-solving, analytical thinking skills.
• Desired: Sees broader picture and longer-term impact on division/company.
• Desired: Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
• Desired: Proven experience in multi-discipline, cross-functional project management in a clinical, highly regulated environment.
• Desired: Track record of success with effectively organizing and managing multiple assignments with challenging timelines across multiple personnel.

Skills

• 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.

Pay

The annual base salary we reasonably expect to pay is $156,900.00-$214,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program.

Benefits

• Retirement savings plan (with company match).
• Paid vacation, holiday and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.