Senior Statistical Programmer

Clinical 

Essential Responsibilities:

• Acts as lead programmer for assigned studies.
• Independently develop, validate, document and troubleshoot SAS programs for the preparation of periodic internal reports, regulatory submissions, and ad hoc analyses.   
• Create and maintain analysis and submission datasets (ADaM, SDTM) in compliance with CDISC standards and regulatory guidance. 
• Design, develop, validate, update, and document SAS programs to generate analysis datasets, data listings, tables, and graphs of high quality in a timely manner. 
• Support submission activities including preparation of data packages, eCTD deliverables, and responses to regulatory agencies,  
• Communicate with team members about statistical programming related to trial timelines, data quality, and results interpretation.
• Develop software tools, SAS macros and utilities to automate programming activities and improve programming efficiency and quality.
• Create SAS macros or other tools to enhance the efficient delivery of statistical services, providing associated used documentation and staff training as needed.
• Program quality checks for clinical study raw data and report the findings.
• Review or author, SDTM and ADaM specifications.
• Manage CROs, including reviewing or validating statistical deliverables of vendors.
• Provides input in the design and development of case report forms and clinical databases.
• Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience.
• Establish and maintain excellent working relationships with critical collaborative partners throughout the company.
• Other duties as assigned.

Essential Physical Characteristics:

On-Site Protocol:

• Bachelor’s degree in Biostatistics, Mathematics, Statistics, Computer Science, or related field.
• Minimum 6 years’ experience in bio-pharma statistical programming.
• Advanced SAS programming skills in SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL with a demonstrated mastery of SAS/STAT procedures.
• Strong expertise in CDISC including SDTM, ADaM, and CDASH.
• Extensive experience in SAS macro functions and dynamic code generations.  
• Experience in regulatory submissions (NDAs and DSURs)  
• High attention to detail, with a focus on quality and traceability in all deliverables. 
• Strong interpersonal and teamwork skills with a collaborative mindset and the ability to manage multiple priorities in a fast-paced and dynamic environment with shifting timelines and evolving needs 
• Take initiatives to solve problems proactively and think critically 
• Willing to adapt to changing business needs, able to pivot between tasks 
• Able to make complex programming and data-related decisions independently. 
• Comprehensive knowledge and deep understanding of statistical programming environments, processes, procedures, and roles for clinical development from Phase 1 through regulatory submission.
• Up to date with CDISC standards, industry trends, best practices, and statistical programming methodology.
• Experience in developing and implementing SOPs.
• Proficiency working with Microsoft Office Suite Products.

Preferred Qualifications:

• Experience in R is preferred.
• SAS certifications are a plus.

Required Key Attributes:

• Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
• Strong problem-solving skills and a proactive attitude towards exploring new approaches.
• Excellent written and verbal communication skills and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role.
• Must be able to work independently with supervision as needed.
• Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment.
• Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.

Compensation:

• This is a full-time position, Monday-Friday, occasional overtime.
• Pay is commensurate with experience.
• Equity-based compensation
• Performance-based bonuses
• 401(k) with Company Match
• Medical, Dental, Vision
• Flexible Spending Account
• Life Insurance
• Employee Assistance Program
• Employee Discounts 
• Gym Membership
• Paid Vacation
• Paid Holidays
• Paid Sick, Jury Duty, Bereavement

Work Authorization:

• United States (Required)
• Background Check
• As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check.

Company Overview:

ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Disclosure Statement:

• The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
• Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
• The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law.
• Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses.
• Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position. 95000.00 To 149000.00 (USD) Annually