Associate Director/Director, Clinical Programming & Data Standards

Associate Director/Director, Clinical Programming & Data Standards Boston, MA, USA Req #272
Tuesday, May 14, 2024
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 Programming 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 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.
•