About this opportunity
Amylyx Pharmaceuticals lists this Associate Director, Clinical Data Programmer opportunity in cambridge, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Associate Director, Clinical Data Programmer
Cambridge, MA
Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).
Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.
The Opportunity
The Clinical Data Management team at Amylyx Pharmaceuticals is seeking an Associate Director, Clinical Data Programmer. This individual will work collaboratively cross-functionally to provide hands‑on data management support, programming support and technical leadership to develop, maintain, validate the clinical database, and run 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 of Clinical Data Programming, you will be required to program in the appropriate languages to create both textual and graphic displays that facilitate data cleaning and review.
Responsibilities
Serve as the inter-department subject matter expert for EDC platforms (Medidata RAVE) including management of the environment as well as the standards library to enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision‑making
Contribute to development process and ensure compliance from a CDM / EDC and data programming perspective including SOPs, standardization of operational and technical methodologies
Provide technical and functional oversight of the day‑to‑day use of CDM systems and related processes, as needed, including EDC build standards, clinical data collection, processing, system integrations, and quality control procedures, timelines, and documentation
Participate in the evaluation and selection of future CDM systems infrastructure and solutions including clinical programming and data visualization tools
Leads the study‑specific design, development, and validation of study clinical data capture systems, ensuring data integrity, CDISC compliance and CRO oversight.
Supports leading data management activities (i.e. DMP creation, CRF creation, edit checks creation, database lock), assisting with database setup, conduct and closeout phases.
Performs UAT of systems and ensures appropriate plans and documentation are in place.
Leads the development of SAS macros, data listings, summary tables and visualizations for supporting periodic and ad hoc data review.
Manages external vendor compliance and quality checks.
Supports Clinical Operations, Biostatistics and Data Management by providing data insight and solving technical data challenges.
Ensures databases adherences to SOPs, 21CRF Part 11, ICH‑GCP and CDISC Standards (CDASH/SDTM)
Acts as a subject matter expert in leading technical initiatives and data management
Required Qualifications
Bachelor’s degree or higher in Life Science or related discipline
8+ years of experience in clinical data management
Extensive experience with clinical data systems (particularly Medidata Rave) and languages like SAS, R or Python
Proven experience in clinical trial programming and database management
Knowledge of Clinical Data Standards such as CDISC CDASH, and SDTM
Provide strong support to Data Management
Experience creating advanced interactive data visualizations from raw data using multi‑languages and applications such as Using SAS, R, Python, RShiny, Power BI, Tableau, Spotfire etc.
Ability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.
Excellent written and verbal communication skills and organizational and documentation skills.
Work Location and Conditions
At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company‑related events as necessary and requested, which may include travel by air, driving or public transportation.
You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote locatio
Compensation
The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.
$188,000 - $211,000 USD
Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy‑related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self‑identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.
As set forth in Amylyx Pharmaceuticals’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:
A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service‑connected disability.
A "recently separated veteran" means any veteran during the three‑year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
An "Armed forces service medal veteran" means a
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Worksite address
cambridge, MA, 02140, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.