Director of Statistical Programming

Kelly Science and Clinical is currently hiring for an excellent opportunity with one of our well-known biotechnology clients. If you are looking for a collaborative and innovative work environment at the forefront of biotech advancements, this is your diamond in the ruff. We are not accepting any contractor backgrounds and will be prioritizing those who have direct sponsor experience vs working for a CRO.

• This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to VP, Biostatistics.
• Location: Remote work from home in US
• Salary: $215-240,000k
• Performance-based bonuses, Stock options, Employee Stock Purchase Plan, 401k plan, medical benefits, PTO, winter shutdown, and more.

Position Overview
We are seeking a highly skilled, dynamic, and innovative Director of Statistical Programming with expertise in statistical programming and data analysis to support clinical development and research initiatives. This individual will lead efforts in reviewing and interpreting data for trends, anomalies, and quality issues, while overseeing the creation and delivery of reports and data extracts to support internal and external activities. The candidate must have expertise in state-of-the-art data processing and statistical analyses. The ideal candidate will have extensive experience in SAS and R programming, advanced Excel skills, and a solid foundation in data analysis and reporting. The candidate must be a dedicated team player with the ability to work effectively across cross-functional teams, fostering collaboration and driving alignment toward shared goals.

Key responsibilities of this role include, but are not limited to:

• Develop, validate, and maintain programs for data cleaning, analysis, and reporting using SAS and R.
• Generate and validate SDTM and ADaM datasets, files, and associated documentation in compliance with CDISC standards.
• Oversee the creation of analysis datasets, tables, listings, figures, for clinical study reports, and publications.
• Act as programming lead for regulatory deliverables, ensuring alignment with ICH, FDA, EMA guidance, and internal pertinent processes and standard operating procedures.
• Collaborate cross-functionally with Biostatistics, Clinical R&D, Regulatory Affairs, and Data Management to support study design, data analyses, and reporting plans.
• Review and contribute to statistical analysis plans (SAPs), case report forms (CRFs), database specifications, validation plans, and programming specifications.
• Provide oversight and direction to external vendors (e.g., CROs), ensuring deliverables meet quality and timeline expectations.
• Interpret clinical data to identify trends, inconsistencies, and quality issues, and provide actionable insights to cross-functional teams.
• Contribute to the development and maintenance of programming SOPs, work practices, and technical standards.
• Support audits and inspections by providing programming documentation and subject matter expertise.

Qualifications

• PhD in Statistics or Biostatistics
• Minimum of 8 years of experience in statistical programming within the pharmaceutical or biotechnology industry
• Proven expertise in SAS and R programming; proficiency in advanced Excel functions and data visualization tools.
• Strong understanding of clinical trial design, data standards (e.g., CDISC SDTM/ADaM), and regulatory requirements.
• Demonstrated ability to lead cross-functional teams and manage complex projects.
• Excellent analytical, problem-solving, and communication skills.
• Experience with data quality assurance and validation processes.
• Ability to work in a fast-paced, dynamic environment with shifting priorities.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.