Senior Statistical Programmer

Role Description

A Senior Statistical Programming is an expert in the management, technical oversight, and quality of statistical programming activities related to the analyses of clinical trial data ensuring timelines and company strategic objectives are met. They contribute to process improvements and initiatives within the Biometrics department as well as mentor and train junior staff members as applicable.

• Lead all aspects of statistical programming activities inclusive of creation, validation, traceability, reproducibility, and maintenance of analysis datasets and statistical outputs.
• Contribute to and review statistical analysis plans and analysis datasets specifications.
• Prepare the electronic submission of clinical trial data to regulatory authorities.
• Anticipate statistical programming resource needs and work with management to ensure adequate long-term resource allocation within a project.
• Provide effective solutions for complex statistical programming tasks.
• Provide input or lead data standardization efforts (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions).
• Create and manage project and study electronic subdirectories ensuring consistency in structure.
• Contribute to the design, creation, and validation of global programming macros that streamline programming activities and increase efficiency.
• Participate in development of new processes or revision of existing processes.
• Keep current with new statistical programming techniques and technical advancements.
• As necessary, provide work direction, guidance, mentoring, influence and support to junior staff.
• Train junior staff in more complex statistical programming techniques.
• Adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
• Perform ad-hoc and cross-functional projects assigned to support business needs and provide developmental opportunities.

Qualifications

• Bachelor’s Degree in Statistics/Biostatistics, Computer Science, Mathematics, or other field of study with at least 7+ years of relevant experience is required; OR
• Master’s Degree in Statistics/Biostatistics, Computer Science, or Mathematics, or other field of study with at least 5+ years of relevant experience is required.
• 5+ years of experience as a statistical programmer in the pharmaceutical industry is preferred.

Requirements

• Demonstrated knowledge and ability in efficient programming techniques.
• Working knowledge of clinical research, Good Clinical Practices, and regulatory requirements/guidelines.
• Technically strong with regard to statistical programming processes and activities.
• Highly proficient in SAS.
• Experience as a lead statistical programmer on several concurrent projects.
• Understanding of CDISC STDM/ADaM guidelines.
• Excellent English verbal and written communication skills; good organizational and interpersonal skills.

Benefits

• Medical, Dental and Vision Plan Options.
• Health and Financial Wellness Programs.
• Employer Assistance Program (EAP).
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability.
• Healthcare and Dependent Care Flexible Spending Accounts.
• 401(k) Retirement Plan with Company Match.
• 529 Education Savings Program.
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks.
• Paid Time Off (PTO) includes: 11 Holidays.
• Exempt Employees are eligible for Unlimited PTO.
• Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day.