Director, Statistical Programming

Summary of Key Responsibilities

• Leads statistical programming teams/activities for complex clinical development Compound(s), including worldwide regulatory submissions. Represents Statistical Programming as part of Clinical Trial Working Groups (CTWG), Clinical Development Teams, and/or Clinical Filing teams, and acts as a key decision-maker with biostatistics and data management on DSSE' analysis/dataset and electronic submission strategies;
• Plans optimal programming and data/analysis review tasks and team member assignments, coordinates and leads programming team delivery/forums; Revisits and aligns staffing plans and programming assignments seamlessly as priorities shift;
• Drives analysis dataset/submission flow with Biostatistics, working closely on the development and review/validation of Statistical plans/shells, CDISC SDTM and ADaM specifications and datasets, TLFs and electronic submissions;
• Drives clinical data review and validation flow with Data Management including the development and review of DM documentation (i.e., Data Review Plans, Data Transfer Agreements, etc.), CDISC SDTM specifications, datasets, P21 reporting, and SDTM Reviewer Guides and define packages;
• Coordinates delivery of PV outputs to Drug Safety to support timely Safety review
• Partners with Clinical Pharmacology to coordinate PK/PD Analyses delivery for Clinical Study Reports, clinical dataset provisioning and other compound data delivery or analytic/modeling needs, as needed;
• Directs internal and external statistical programmers and vendors to deliver high-quality and timely delivery; maintains strong collaboration and partnership with preferred vendors through two-way communication, prioritization, collaboration, proactive issue detection and remediation;
• Leads team to complete complex SAS tasks, including development of SDTM production/validation, ADaM datasets/specifications production/validation, TLF delivery, Defines, reviewer guides, other programming tasks as requested or TLF annotations for multiple studies and/or across an integrated summary/compound;
• Mentor's statistical programmers working on the program; Promotes productive work environment through teamwork, quality, innovation and leadership of Programming and DSSE forums. Ensures team compliance with SOPs and departmental standards;
• Leads process, macro/tool or standards initiatives or sub teams to achieve programming efficiency and/or programming effectiveness; Brings forward industry best practices to DSS processes, systems, or standards. Authors SOPs/best practices and rolls out training/methods;
• Exercises leadership within SP Department, as well as the broader DSSE Expertise Area;
• Communicates and influences effectively across various levels and relevant functions, CTWG, Filing teams and/or senior stakeholders, on relevant Project or SP topics;
• Supervises, coaches and develop statistical programmers in their day to day tasks and supports their career development and learning,

Qualifications

Typically demonstrates the following, or equivalent, qualifications:

• At least 12 years' industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent;
• At least 3 years as a people manager, including authorship of performance evaluations
• Significant experience leading programming teams in support of clinical development compounds to report the results of clinical trials, integrate analyses across a program, and prepare data/analysis for electronic NDA or BLA submission;
• Expert at the creation of technical programming specifications, standards and producing complex, validated SAS programs;
• Demonstrated experience in leading teams to implement submission-ready CDISC standards, including SDTM, and ADaM, Data Reviewer guides, and Define xml for multiple studies across a compound and for regulatory submission;
• Excellent collaboration and partnership skills with cross-functional peers in Clinical Operations, Regulatory, Medical Writing, Safety, Clinicians, Medical Affairs, etc. and/or vendor relationships;
• Expert knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL with a demonstrated mastery of SAS/STAT procedures;
• Experience independently developing processes/SOPs, Standards or implementing programming best practices;
• Experience leading and maintaining positive vendor relationships in support of a compound/program in the delivery of quality programming support;
• Excellent written and oral communication, planning and organizational skills required;
• Expert problem-solving and decision-making skills with respect to best practices for Programming, and compound, data or submission strategies
• Experience leading statistical programming process or technology improvement projects through to implementation
• Bachelor's Degree required, Master's Degree Preferred, in areas of computer science, statistics, mathematics or information sciences.
• Clear alignment with Alnylam Core Values:
  • Commitment to People
  • Innovation and Discovery
  • Sense of Urgency
  • Open Culture
  • Passion for Excellence

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.