Sr Manager, Statistical Programming

Senior Manager, Statistical Programming

Overview

Alnylam (Nasdaq: ALNY) is delivering on a bold vision to turn scientific possibility into reality,

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 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.

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The Senior Manager Statistical Programming will provide leadership and expert-level hands-on support to programmers. The senior manager may also guide the professional development of statistical programmers within the company.The position requires a broad, comprehensive and detailed understanding of statistical programming languages and software, industry best practices, clinical trial databases, regulatory filings, and pharmaceutical drug development.

Summary of Key Responsibilities

• Oversees the work of internal statistical programmers.Provides technical guidance and mentoring;
• Provides timely support to study teams on all programming matters according to productstrategies;
• Performs, plans and coordinates project work to ensure timely, quality delivery across multiple projects;
• Contributes to strategic initiatives to improve departmental processes and scalability;
• May function as lead programmer to produce or validate tables, listings, figures and analysis datasets;
• Writes specifications to describe programming needs;
• Creates and validates global macros or systems that streamline repetitive operations to increase programming efficiency;
• Keeps abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation;
• Provides input into, or leads general standardization efforts (e.g., CRFs, query checks, standard statistical programs, data presentations);
• Assists in developing programming processes consistent with industry best practices;

• Reviews DMP, eCRF specs, and other clinical data management documents;

• Reviews statistical analysis plans and other related documents;
• Partners with or oversee CROs or Programming vendors to perform any of the above tasks;

• Other duties as assigned.

Qualifications

• At least 8 years' industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent; At least 2 years management experience;
• Knowledge of clinical trials and experience in using SAS to report the results of clinical trials and/or integrated analysis for submission;
• Experience in constructing technical programming specifications and producing validated SAS programs
• Strong experience in working with CDISC standards, including SDTM, and ADaM and define documentation;
• Excellent knowledge of applied statistical methodologies;
• Excellent knowledge of SAS Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT;
• Good communications and organizational skills required;
• Bachelor's Degree required, Master's Degree Preferred.

• Clear alignment with Alnylam Core Values:
  • Commitment to People
  • Innovation and Discovery
  • Sense of Urgency
  • Open Culture
  • Passion for Excellence

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

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.