Associate Director of Statistical Programming

Key Responsibilities

• Effectively manages a group of full time and contract statistical SAS programmers by holding regular meetings, coaching, goal setting, yearly performance reviews, and resolving issues.
• Uses creative thinking and broad expertise to develop innovative and efficient programming solutions to analyze complex clinical trial data.
• Provides leadership for programming activities to support clinical trials. Acts as a key collaborator and strategic partner with biostatistics in ensuring that drug-development plans are executed efficiently with timely and high-quality deliverables.
• Reviews and contributes to the development of statistical analysis plans, TLF specifications, study CRFs, edit check specifications, and database design specifications.
• Programs SAS edit checks to assist data management’s data cleaning activities.
• Develops and maintains SDTM and ADaM data sets specifications for clinical studies.
• Programs SDTM and ADaM data sets for clinical studies.
• Develops SAS programs to analyze and report clinical trial data for CSRs, regulatory submissions (e.g., DSURs, NDAs/BLAs, briefing documents), publications, and presentations.
• Performs and manages critical tasks involved in the assembly of the module 5 data package for NDAs/BLAs.
• Ensures departmental compliance to CDISC and FDA standards for submitting data, programs, and analyses for regulatory submissions
• Drives the strategy for maintaining and enhancing the current programming infrastructure.
• Establishes and maintains programming standards, global SAS macros libraries and templates to ensure efficient and consistent programming across all clinical studies.
• Develops and maintains the SAS environment and license for the biometrics department.
• Develops and maintains SOPs and work Instructions to comply with regulatory requirements.
  

Education and Experience

• Bachelor's degree in a computer science, mathematics, statistics, or health-related field and a minimum of 12 years of relevant experience, including experience in the pharmaceutical or life sciences industry or an equivalent combination of education and experience may be considered.
• 3+ years of management experience.
• Proven interpersonal skills and the ability to lead through example and to establish an environment fostering effective and collaborative working relationships.
• Good organizational skills and the ability to work effectively in a high paced, fast changing environment. Results-oriented.
• Knowledge of FDA regulatory requirements and ICH/GCP guidelines preferred.
• Extensive knowledge of CDISC standards and familiarity with SEND standards.
• Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines, with background in oncology preferred.
• Excellent knowledge of SAS programming and applications in the pharmaceutical/biotechnology industry.
• Demonstrated understanding of and experience with clinical trial data and data manipulations, analysis and reporting of analysis results.
• Excellent overall computer proficiency required (PC-Windows preferred) and proficiency in Microsoft Word, Excel, PowerPoint, and SharePoint.
• Clear and concise verbal and written communication skills.
• Detail oriented with excellent analytical and problem-solving skills.
• Ability to prioritize and handle multiple tasks and projects in a fast-paced environment.
• Ability to work independently and in a highly collaborative team environment.
• Dedication to quality and reliability in all work tasks.
• Self-motivated, eagerness to grow professionally and commitment to self-development.

Skills and Abilities

• Proficiency in SAS and other statistical software such as R.
• Demonstrated ability to lead and develop a team of motivated SAS programmers.
• Proven ability to collaborate with other groups in clinical development and within Biometrics.
• Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.