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Senior Manager/Associate Director, Biostatistical Programming

Company: Relay Therapeutics
Location: Cambridge
Posted on: April 4, 2021

Job Description:

Senior Manager/Associate Director, Biostatistical Programming As Senior Manager/Associate Director, Statistical Programming, you will be accountable for delivery, integrity and quality of Relay's statistical programming across the clinical studies. You will be an integrated member of the Relay Tx scientific team, responsible for the in-house statistical programming expertise for the execution of clinical studies that will translate Relay's innovative science into impactful medicines for patients. You will report to the Head of Biometrics. Your Role:

  • You will function as lead programmer to provide technical and business expertise in support of statistical programming deliverables.
  • You will oversee the day-to-day statistical programming activities, timelines and deliverables for in house statistical programming as well as outsourced services.
  • You will ensure compliance with global regulatory requirements and quality standards.
  • You will lead/review SDTM and ADaM specifications, Defines, Reviewer's Guide for regulatory submissions, CDISC compliance.
  • You will generate/validate CDISC SDTM, ADaM compliant datasets and TLFs based on SAP.
  • You will create, manage and maintain the programming specifications for the integration of data across studies in support of ISS/ISE.
  • You will produce and/or validate tables, listings, figures and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses; write specifications to describe programming needs.
  • You will identify problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group. Your Background
    • A master's degree in statistics, mathematics, computer science, or related scientific/medical field is preferred.
    • 6+ years of (SAS) statistical programming experience in the pharmaceutical/biotechnology industry as a statistical programmer. Oncology experience is preferred.
    • Advanced SAS programming skills - procedures and options commonly used in clinical trial reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC, experience generating listings, tables, figures desirable.
    • A strong and hands-on knowledge of CDISC SDTM/ADaM models and transforming raw data into these standards.
    • Experience in CRO and vendor oversight.
    • A motivated self-starter who is capable of flourishing in a fast-paced small company environment.
    • A creative problem-solver with excellent communication.
    • Strong interpersonal and organizational skills, with a high degree of attention to detail.-- We believe in building balanced teams and a place where our people can be their best self every day. We encourage people from underrepresented backgrounds to apply.-- Relay Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. Our Culture: At Relay Tx, we believe that along with our people, our culture is our greatest asset. In fact we're proud to share we were named as one of the Boston Business Journal's "Best Places to Work " in 2017, the--#1 place for small companies --in 2018 & the--#2 place for small companies --in 2019. To drive that culture, no one will stop you or hold you back. Instead, we will give you the tools and colleagues to push forward relentlessly and cheer you on as you go. If this resonates with you, drop us a line. About Relay Therapeutics Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology and genetic diseases. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process. Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you're excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!

Keywords: Relay Therapeutics, Cambridge , Senior Manager/Associate Director, Biostatistical Programming, Executive , Cambridge, Massachusetts

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