17 days old

Senior Manager, Statistical Programming, Early Phase

Alnylam Pharmaceuticals
Cambridge, MA 02139
  • Job Code
    220312

Overview

Alnylam (Nasdaq: ALNY) is delivering on a bold vision to turn scientific possibility into reality, with a robust RNA interference (RNAi) therapeutics platform. As the pioneer in RNAi and the leading RNAi therapeutics company, we have always been uncompromisingly dedicated to translating the breakthrough science into transformational medicines to help as many people as possible. Long focused on rare and genetic diseases, our scientific advances are now allowing us to bring the power of RNAi therapeutics to more prevalent diseases and as a result, we are beginning to recognize the full potential of this new class of medicines.

Alnylam is committed to its journey to become a top 5 independent, global biopharma company. We are already admired and recognized for our dedication to patients, company culture that empowers people to do their best work, track record of scientific innovation, social responsibility, and commercial excellence.

Founded in 2002, and headquartered in Cambridge, Mass., Alnylam has over 1,650 employees at work across the globe. We are seeking smart, passionate, "change the world" kind of people who are ready to say, "challenge accepted" to our mission. Thanks to the commitment of every employee globally, Alnylam is proud to have been recognized as one of Fast Company's 2021 Best Workplaces for Innovators, a Science Magazine Top Employer three years in a row (2019-2021), a Boston Globe Top Places to Work seven years in a row (2015-2021), a Great Place to Work in Asia, Japan, Brazil, the U.K., Germany, Spain, Netherlands, Italy, France and Switzerland, Seramount's 100 Best Companies (formerly Working Mother 100 Best Companies) and Best Companies for Dads, Bloomberg's Gender Equality Index two years in a row (2021-2022), among others. At Alnylam, we are committed to fostering a diverse, equitable and inclusive work environment, culture, and workforce, and we support several Employee Resource Networks.

The Senior Manager Statistical Programming will work on early phase studies, providing managerial leadership to programmers and if needed, an expert-level hands-on support to programmers. The senior manager will 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

  • O versee the work of internal statistical programmers on early phase studies. Provides guidance and mentoring;
  • Provide timely support to the study teams on all programming matters according to product strategies;
  • Contribute to strategic initiatives;
  • May function as lead programmer to produce or validate tables, listings, figures and analysis datasets;
  • Write specifications to describe programming needs;
  • Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency;
  • Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation;
  • Provide input into, or lead general standardization efforts (e.g., CRFs, query checks, standard statistical programs, data presentations);
  • Assist in developing programming processes consistent with industry best practices;
  • Review DMP, eCRF specs, and other clinical data management documents;
  • Review statistical analysis plans and other related documents;
  • Partner with or oversee CROs or Programming vendors to perform any of the above tasks;
  • Other duties as assigned.

Qualifications

  • At least 10 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.
  • If employed in the U.S., being fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required
  • 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.





Posted: 2022-06-17 Expires: 2022-07-16
Sponsored by:
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Senior Manager, Statistical Programming, Early Phase

Alnylam Pharmaceuticals
Cambridge, MA 02139

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