Principal Statistical Programmer

About the Role:

The Principal Statistical Programmer is responsible for all statistical programming aspects of one or more clinical trials and global regulatory submission. The position ensures that all development and analysis supporting clinical study reports and regulatory filings are executed efficiently with timely and high-quality deliverables. It is a highly technical role with a strong understanding of all phases of the drug development process and extensive, hands-on experience in regulatory activities.  The role may develop tools and utilities supporting the Statistical Programming environment and infrastructure and enforcing standard programming processes. 

Essential Duties and Responsibilities:

• Using advanced features in SAS, or other programming languages, serves as a subject matter expert who develops all files (e.g., SDTM datasets, ADaM datasets, tables, listings, and figures in word and pdf form), documents (e.g., SAS logs/lists/documentation, Define XML), and analyses (e.g., safety and efficacy) necessary to support an electronic submission in eCTD format, including ISS/ISE
• Performs quality control checks of SAS code and output produced by other Statistical Programmers to ensure accuracy and consistency and ensure compliance with SOPS and global regulations (e.g., ICH, FDA, EMA, PMP)
• Independently and collaboratively solves complex clinical trial reporting problems and demonstrates technical proficiency, and exercises judgment in supporting daily operations and ensuring that study tasks are completed accurately and promptly
• Works cross-functionally within Biometrics, including Statistical Programmers, Biostatisticians, Data Management, and other departments engaged in providing data and submission-related activities and teams that work on standard operating procedures, guidelines, process improvements, system validation and acquisition, customization, and integration of new tools and technologies
• Provides technical and project management skills to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission
• Creates and maintains project timelines, delegating programming assignments to internal and external programming resources
• Trains and onboards new staff, both internal and external and serves as a mentor to other statistical programmers at lower levels 

Education and Experience:

Education:

• Master’s degree (preferred) or bachelor’s degree in mathematics, Statistics, Biostatistics, Computer Science, Data Science, or related discipline

Experience:

• 15 years of combined experience. Typically requires 7-8 or more for M.S. and 9-10 or more for B.S. years of work experience in Biotech, Pharmaceuticals, or Clinical Research Organization in all phases of clinical trials (Phases I to IV). Oncology experience is a plus. 
• A proven expert in SAS language, including Base SAS, macro, SAS/STAT, SAS/GRAPH, SAS/Macro, and SQL. R and Python experience is a plus. Must have a written and verbal command for various safety and efficacy procedures in SAS (e.g., MIXED, LIFETEST, and PHREG procedures). 
• Solid understanding of regulatory (FDA, EMA, PMDA) requirements.
• Demonstrable knowledge of CDISC standards. Must have extensive experience developing, validating, and translating specifications mapping EDC data to SDTM, SDTM to ADaM, and ADaM to TLFs. Must have extensive experience developing and validating the data reviewers' guides, compliance issue summaries, and define.xml. 
• Advanced understanding of regulatory requirements relevant to Statistical Programming (e.g., GCP, ICH) and clinical study practices, procedures, and methodologies.
• In-depth knowledge of clinical development and medical data.
• A role model in technical leadership and project management skills.
• Experience managing and overseeing fully outsourced statistical programming activities
• Experience developing standard tools and utilities in SAS, R, Python, or other programming languages is preferred

License/Certificate:

Base, Advanced, and Clinical Trial SAS certificates a plus

Skills:

Technical:

• Proficiency in all SAS language, procedures, and functions commonly used in clinical trial reporting including BASE SAS, SAS/STAT, SAS/MACR, SAS/ODS, SAS/SQL, and SAS/GRAPH
• Experience in other programming languages such as R or Python is preferred
• Experience with a multitude of operating systems (e.g., Windows, Unix, Linux, etc.)
• Expert knowledge of CDISC Standards, Pinnacle 21, ICH/eCTD technical requirements, Medical Dictionaries (e.g., MedDRA and WHO-Drug), and all phases of clinical trials.
• Extensive global regulatory submission experiences (e.g., FDA, EMA, PMDA)
  

Leadership:

• A strong team player with the ability to collaborate in cross-functional teams.
• Able to work cooperatively and independently in a fast-paced, matrixed environment
• Demonstrates ability to translate & present complex information to others effectively.
• Ability to influence without direct authority
• A detail-oriented, pro-active, enthusiastic, and goal-oriented personality  

Communication:

• Excellent communication and interpersonal skills to effectively interface with others
• Must communicate, develop, and maintain strong relationships with regulatory agencies (e.g., FDA, PMDA, etc.), internal stakeholders, and external stakeholders (e.g., CROs) 
• Practical technical writing skills, especially the ability to clearly and succinctly author documents

Other:

Ability to travel domestically for meetings as necessary

The expected salary range for this position is $147,000 – $195,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.