Senior Manager/Associate Director, Biostatistical Programming
Company: Relay Therapeutics
Posted on: April 4, 2021
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
- 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
- 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,
Keywords: Relay Therapeutics, Cambridge , Senior Manager/Associate Director, Biostatistical Programming, Executive , Cambridge, Massachusetts
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