ASSOCIATE DIRECTOR/DIRECTOR, CLINICAL PROGRAMMING & DATA STANDARDS
Company: Xenon Inc
Location: Boston
Posted on: October 14, 2024
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Job Description:
Who We Are:
Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused
biopharmaceutical company committed to discovering, developing, and
commercializing innovative therapeutics to improve the lives of
people living with neurological and psychiatric disorders. We are
looking for great people who thrive in a respectful, collaborative,
inclusive, and productive culture to join the Xenon team.
What We Do:
We are advancing an exciting product pipeline to address
indications with high unmet medical need, including epilepsy and
depression. Our flagship azetukalner program represents the most
advanced potassium channel modulator in clinical development for
multiple indications. Building upon the positive results and
compelling data from our Phase 2b X-TOLE study in adult patients
with focal epilepsy, our Phase 3 epilepsy program includes multiple
clinical trials evaluating azetukalner in patients with focal onset
seizures and primary generalized tonic-clonic seizures. In 2024, we
are planning to initiate a Phase 3 azetukalner program in major
depressive disorder, based on topline data from our Phase 2 X-NOVA
clinical trial. In addition, we are proud of the leading-edge
science coming out of our discovery labs, including early-stage
research programs that leverage our extensive ion channel expertise
and drug discovery capabilities to identify validated drug targets
and develop new product candidates. Backed by a strong balance
sheet to support our growth plans, we continue to build a fully
integrated, premier neuroscience company with strong discovery,
clinical development, corporate, and commercial operations.
About the Role:
We are seeking an Associate Director/Director, Clinical Programming
& Data Standards to join our team. This role will provide
expert-level hands-on principal programming support and technical
leadership to develop, maintain, validate, and run SAS computer
programs that access, visualize, and report clinical trial data, in
accordance with various clinical plans, ICH guidelines, and
applicable regulatory requirements. As an Associate
Director/Director of Clinical Programing and Data Standards, you
will be required to program in the appropriate languages to create
both textual and graphic displays that facilitate data cleaning and
review. The ability to work independently and expert SAS/Macro,
SAS/SQL, programming experience is required.
This position reports to the Executive Director, Data Management
and will be located in Vancouver, BC, Canada or Boston, MA, USA. We
will consider other jurisdictions for exceptional candidates. The
level of the position will be commensurate with the candidate's
education and industry experience.
RESPONSIBILITIES:
--- Lead and manage all Clinical Programming activities on project
or study level using eDC and external raw data.
--- Work cross-functionally to define and implement a data
visualization environment, enabling data review for medical
monitoring and clinical analysis.
--- Lead efforts to programmatically improve the efficiencies of
CDMs 'processes as they relate to data monitoring and cleaning.
--- Program data listings to support ongoing Medical Monitoring
review of data, specifically AE data to facilitate AEs/Events of
Special Interest adjudication.
--- Create data visualizations, including dashboards, to present
clinical data effectively.
--- Contribute to the development and review of Standard Operating
procedures (SOPs), related to clinical data management
programming.
--- Conduct Clinical Programming to support clinical data
management, data cleaning and data review, as well as external data
reconciliation, in accordance with standards/SOPs or study specific
guidelines.
--- Perform data checks as needed to ensure integrity and
correctness of data.
--- Program Patient Profile listings, incorporating external data,
and exception reports.
--- Perform QC/validation of clinical data listings and edit
checks.
--- Develop and maintain SAS macros, templates and utilities for
data cleaning and reporting following good programming
practices.
--- Support the development of clinical programming SOPs and
standard processes as needed.
--- Develop and propose short- and long-term goals for the
department in accordance with overall Company strategies.
--- Recruit, lead, direct, develop, coach and evaluate direct
reports, if any, in accordance with the Company's Human Resource
policies and practices
--- Act in accordance with Company policies, including, for
example, the Code of Business Conduct and Ethics and ensure
policies are understood and followed by direct reports, if any
--- Other duties as assigned.
QUALIFICATIONS:
--- A minimum of a bachelor's degree in a scientific, computer
science or related field, training in statistics preferred.
--- A Clinical Programmer requires a minimum of 8-10 years of
clinical programming. An equivalent combination of education and
experience may be considered.
--- Must have a minimum of 5 years' experience in a data management
programming lead position.
--- Experience in a pharma, biotech, or CRO environment is
required.
--- Knowledge of multiple phases of clinical development and
experience in using SAS, or equivalent programming language, for
clinical trials
--- Hands-on experience and in-depth knowledge in CDISC standards
is preferred
--- Excellent knowledge of SAS/Macro, SAS/SQL, SAS/GRAPH, and
SAS/STAT
--- Experience in CNS, pediatric rare disease area preferred.
--- Strong communication and team player with strong interpersonal
skills required.
--- Solid analytical and proactive problem-solving skills.
--- Outstanding organizational skills with ability to multitask and
prioritize key tasks.
The base salary range for this role is $165,000 to $233,300 USD; we
will consider above this range for exceptional candidates. Base
salary is determined by a combination of factors including, but not
limited to, education and other qualifications, years of relevant
experience, and internal equity.
Our Total Rewards program includes base salary, target bonus, and
stock options, as well as a full range of benefits including
medical, dental, vision, short-& long-term disability, accidental
death & dismemberment, and life insurance programs, Employee
Assistance Program, travel insurance, and retirement savings
programs with company matching contributions.
Xenon encourages time to rest and re-charge through vacation,
personal days, sick days, and an end-of-year company shutdown.
Xenon highly values employee development and has an expanding
Training, Learning & Development program, including a Tuition
Assistance program for advanced degrees.
US positions only: Xenon Pharmaceuticals USA Inc. participates in
the E-Verify program in all states in which we hire. Learn more
about the E-Verify program here.
To apply for this position, click Apply Now to complete the
application. We thank all applicants for their interest; however,
due to the volume of applicants, only those chosen for interview
will be contacted.
Apply Now
Keywords: Xenon Inc, Methuen , ASSOCIATE DIRECTOR/DIRECTOR, CLINICAL PROGRAMMING & DATA STANDARDS, Executive , Boston, Massachusetts
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