Associate Director, Statistical Programming
Cambridge, MA
Relay Therapeutics
Relay Therapeutics® puts protein motion at the heart of drug discovery to dramatically expand therapeutic possibilities.The Opportunity:
As 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.
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:
- You should ideally have a master’s degree in statistics, mathematics, computer science, or related scientific/medical field.
- You have 6+ years of (SAS) statistical programming experience in the pharmaceutical/biotechnology industry as a statistical programmer. Oncology experience is preferred.
- You have 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.
- You have a strong and hands-on knowledge of CDISC SDTM/ADaM models and transforming raw data into these standards.
- You are a motivated self-starter who is capable of flourishing in a fast-paced small company environment.
- You are a creative problem-solver with excellent communication.
- You have strong interpersonal and organizational skills, with a high degree of attention to detail.
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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. 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!
* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰
Tags: CDISC Computer Science Drug discovery Mathematics Pharma SAS Statistics
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