Associate Director, Statistical Programming Data Standards

The Associate Director, Statistical Programming Data Standards is responsible for statistical programming activities in support of Data Standards stewardship across all compounds/vendors, including collaboration within Data Sciences, Clinical Development, and other functional representatives to develop, maintain and document clinical data standards. This role also acts as the statistical programming subject matter expert (SME) to oversee and manage outsourced/internal SDTM programming activities, including responsibility for the data standards technical decision-making, and project leadership to oversee and ensure the quality and timely delivery of SDTM deliverables. He/she will also consult or support development and dependencies across other related Data Standards (i.e., Analysis Dataset models).  He/she will lead efforts collaboratively with Biostatisticians, Clinical Data Managers, Statistical Programmers, and SDTM or Clinical Data vendors in the overall planning, governance and oversight of data standards activities to ensure proper utilization and adherence of data standards.

Summary of Key Responsibilities

• Provides technical and/or operational leadership in the delivery and application of industry clinical data standards within the statistical programming data flow (i.e., SDTM, ADAM, DEFINE) for clinical studies, drug programs, and/or in support of drug application submissions.
• Implements standards governance framework that supports data standards strategies and processes in alignment with the vision developed by Alnylam’s Data Standards Council, DSS Leadership, and industry-based standards policies and procedures.

• Acts as a data standards SME in development of standards management strategy and ongoing development and maintenance of standards across Alnylam’s portfolio (i.e., CRF to Submission, Drug Program level standards).
• Ensures synchronization of Data Collection Standards with SDTM Standards and applicable company tools/system requirements in collaboration with CRF/Non-CRF Data Collection and SDTM Standards SMEs.
• Makes strategic programming data standards decision-making and prioritization, including review of Case Report Form (CRF) annotation and SDTM datasets for studies, Drug program and/or Portfolio level.
• Identifies data inconsistencies with respect to data standards compliance and proposes solutions that support data review/efficiencies including ensuring robust master dataset specifications and correct interpretation of protocol, analysis and CDISC compliance requirements. 
• Ensures study or program-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and integrity.
• Works closely with Data Management on development of data standards to support data collection requirements; including but not limited to specification of Data transfer agreements (DTAs) in alignment with downstream SDTM and other dataset formats, CRF Standard data collection elements, and external data oversight/strategies to ensure downstream compliance for submission.
• Responsible for developing, managing and maintaining libraries of CDISC-related metadata, terminology, and related standards. Provides governance oversight to ensure consistency in metadata use and development.
• Manages internal and vendor statistical programming data standardization or mapping support; Maintains strong collaboration resulting in data/standards quality with preferred vendors.
• Performs, plans, and coordinates study or program data standardization project work to ensure timely, quality delivery across multiple projects, or across a drug program.
• Leads cross-functional efforts/teams in the development of data standards improvements that streamline repetitive operations to increase programming or data standards efficiency.
• Leads Data Standards Council as needed to align on near-term and longer-term data standards infrastructure priorities, plans, and training.
• Actively monitors new regulatory requirements related to data standards and/or data submissions; Communicates and provides impact assessment / consultancy to Data Sciences or specific project teams.
• Participates in the evaluation and implementation of internal and external software solutions to support the management and usage of standards.
• Capable in developing in-house capabilities using R studio or other software packages.

Qualifications

• Minimum of 10 years’ industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent.
• Minimum of 5 years in-depth data standards experience, specifically SDTM compliance and oversight.
• Experience as a Programming manager (FTEs, Functional Service Providers or vendors).
• Experience leading Data Standards governance activities, including data standard decision-making and training/communication. 
• Expert understanding of CDISC standards; including but not limited to CDASH, SDTM, ADAM, Controlled Terminology, DEFINE.
• Experience in developing data analyses tools using coding languages such as R and Python is an advantage.
• In depth knowledge of regulatory requirements, industry standards, and industry best practices for data standards development and implementation.
• Enhanced understanding of data collection systems and tools including electronic case report forms and data transfer agreements.
• Proficiency in understanding statistical programming environments, processes, procedures, and roles.
• Experience developing SOPs, Standards or implementing programming best practices.
• Experience overseeing vendors in the delivery of quality data standards/data delivery and programming support.
• Experience in implementation or usage of a Metadata Repository to manage standards is an advantage.
• Excellent written and oral communication and organizational skills required.
• Bachelor’s Degree required, master’s degree Preferred, in areas of computer science, statistics, mathematics or information sciences;

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.