Associate Director, Statistical Programming

Role Summary

The Associate Director, Statistical Programming is responsible for statistical programming activities in support of clinical trials including technical and project leadership overseeing the quality and timely delivery of all statistical programming deliverables for studies or for a submission. He/she ensures the team develops, maintains, validates and runs quality SAS programs that access, visualize, analyze, and report clinical trial data in accordance with statistical analysis plans, ICH guidelines, and applicable regulatory requirements. While SAS expertise is required, experience with R programming, particularly data visualization and exploratory analysis is strongly preferred.

Responsibilities

• Provides technical and/or operational leadership in the delivery of high quality and timely statistical programming for clinical studies, drug programs, and/or in support of NDA submissions.
• Works closely with Biostatistics to implement statistical analysis of clinical trial data, working closely on the development and validation of CDISC ADaM specifications and datasets, and TLFs for analyses to support regulatory, medical affairs, and market access needs.
• Works closely with Data Management on cross-functional data review and the development and validation of CDISC SDTM specifications and datasets and define packages, may also support Drug Safety to support safety data review and reporting needs, and/or Clinical Pharmacology to support their dataset creation and analytic needs.
• Manages internal and vendor statistical programming support; Maintains strong collaboration and governance with preferred vendors.
• Writes SAS and R code that produces or validates tables, listings, figures and analysis datasets, in support of clinical studies or complex integrated analyses for submission.
• Performs, plans and coordinates project work to ensure timely, quality delivery across multiple projects, or across a drug program.
• Writes specifications to describe programming needs, including development and maintenance of complex / ADaM specifications and reviewer guides.
• May lead the creation and validation of global macros or systems that streamline repetitive operations to increase programming efficiency.
• Provides input into, or leads general standardization efforts (e.g., CRFs, query checks, standard statistical programs, data presentations).
• Leads efforts to develop programming processes consistent with industry best practices.
• Reviews and provides expert input to DMP, eCRF specs, and other clinical data management documents; Reviews and provides expert input to statistical analysis plans and other related documents.
• Partners with or oversees CROs or Programming vendors to perform any of the above tasks.

Qualifications

• At least 10 years‚Äô industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent;
• Experience as a Programming manager (FTEs, Functional Service Providers or vendors);
• Experience leading programming teams in support of clinical trials to report the results of clinical trials, integrate analyses across a program, or prepare data/analysis for electronic NDA or BLA submission;
• Experience in constructing technical programming specifications and producing complex, validated SAS programs;
• Demonstrated experience in working with CDISC standards, including SDTM, and ADaM, and Define xml;
• Proficiency in understanding of statistical programming environments, processes, procedures, and roles;
• Excellent knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL with a demonstrated mastery of SAS/STAT procedures;
• Preferred experience in R programming;
• Experience developing SOPs, Standards or implement programming best practices;
• Experience overseeing vendors in the delivery of quality programming support;
• Excellent written and oral communication and organizational skills required;
• Bachelor‚Äôs Degree required, Master‚Äôs Degree Preferred, in areas of computer science, statistics, mathematics or information sciences.
• Clear alignment with core values: Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture, Passion for Excellence.

Skills

• SAS proficiency (SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, SAS/SQL);
• R programming and data visualization preferred;
• CDISC standards (SDTM, ADaM, Define XML) experience;
• Technical programming specification development and reviewer guides;
• Vendor management and cross-functional collaboration;
• Strong communication and organizational skills.

Education

• Bachelor‚Äôs Degree required; Master‚Äôs Degree preferred in computer science, statistics, mathematics or information sciences.