Alnylam Pharmaceuticals

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Associate Director, Statistical Programming (Finance)



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. He/she promotes strong collaboration with Biostatistics to support analyses for regulatory, medical affairs, and market access needs, as well as strong collaborative relationships with Data Management, Safety, and Clinical Pharmacology. The position may also include people management responsibilities for statistical programmers. The position reports to the Senior Director of Statistical Programming.

Summary of Key Responsibilities

  • Provides technical and operational leadership in the delivery of high quality and timely statistical programming for clinical studies, drug programs, and/or in support of NDA submissions.

  • Promotes strong collaboration with Biostatistics to implement statistical analysis of clinical trial data, working closely on the development and validation of ADaM specifications and datasets, define packages, and TLFs for analyses to support regulatory, medical affairs, and market access needs.

  • Promotes strong collaboration with Data Management on cross-functional data review and the development and validation of SDTM specifications and datasets and define packages, the collaboration with Safety to support safety data review and reporting needs, and the collaboration with Clinical Pharmacology to support their dataset creation and analytic needs.

  • Manages and/or mentors Alnylam statistical programmers, and is a key member of the Statistical Programming leadership team.

  • Manages internal and vendor statistical programming support; Maintains strong collaboration and governance with preferred vendors.

  • Writes SAS programs that produce or validate tables, listings, figures and analysis datasets, in support of clinical studies or complex integrated analyses for submission.

  • Develops and follows good programming practices, mentors other programmers in how to appropriately document SAS code.

  • 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.

  • Leads the creation and validation of 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).

  • 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.

  • Other duties as assigned.

    Qualifications

  • At least 10-15 years' industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent;

  • Experience as a people manager, including authorship of performance evaluations;

  • Demonstrated 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;

  • Strong 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;

  • Expert proficiency, complete knowledge and 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;

  • 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's Degree required, Master's Degree Preferred.

  • Clear alignment with Alnylam Core Values:

    o Commitment to People

    o Innovation and Discovery

    o Sense of Urgency

    o Open Culture

    o Passion for Excellence

    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 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 2022, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2023 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. Alnylam is an E-Verify employer.

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