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
Reporting into the Statistical Programming function, you will be responsible for providing hands-on programming support and technical guidance on clinical trials and regulatory submissions. In this role you will lead design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for individual studies. You will participate in departmental and cross-functional technology development and process improvement initiatives.
Responsibilities
- Effectively design and code SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s).
- Produce and deliver CDISC and regulatory compliant SDTM, and ADaM standard datasets including datasets specifications for datasets programming.
- Develop and execute statistical analysis and reporting deliverables (tables, figures and listings (TFLs)) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements.
- Perform quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets, fit-for-purpose analysis datasets, and TFLs.
- Create and review eCTD documents to support regulatory submission package.
- Provide programming support for building integrated summary of safety/efficacy datasets and analysis.
- Provide programming support for ad hoc analyses and data listing review.
Required Qualifications
- MS in Statistics, Computer Science, or a related field with at least 6 years of SAS programming experience in the pharmaceutical or biotech industry. (BS in Statistics, Computer Science or related field with at least 8 years’ experience in pharma or biotech also considered).
- Proficient in SAS programming.
- In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
- Working knowledge of R strongly preferred.
- Experience in leading statistical programming to early and late phase clinical trials, integrated summary safety/efficacy datasets and analysis, electronic submission data package in the eCTD format and regulatory submissions (NDA, MAA).
- Experience with FDA and ICH regulations and guidelines.
- 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.
- Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.
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.
- You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.
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.
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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.
Skills Required
- MS in Statistics, Computer Science, or related field with at least 6 years of SAS programming experience in pharmaceutical or biotech (BS with 8 years considered)
- Proficient in SAS programming (BASE/SAS, SAS/STAT, SAS/GRAPH, SAS MACROS)
- In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements
- Working knowledge of R
- Experience leading statistical programming for early and late phase clinical trials, integrated summary safety/efficacy datasets and analysis, and regulatory submissions (eCTD, NDA, MAA)
- Experience with FDA and ICH regulations and guidelines
- Ability to manage multiple projects, prioritize conflicting demands, and adapt to changing priorities
- Excellent written and verbal communication, organizational, and documentation skills
- Ability to work effectively on multidisciplinary teams (Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs)
What We Do
Amylyx Pharmaceuticals, Inc. is a global company committed to the mission of discovery and development of treatments for relentless and progressing neurodegenerative diseases. We work collaboratively across everything we do, aspiring to help support and create #MoreMoments for the neurodegenerative disease community. Community Guidelines: https://bit.ly/3C1v1wz Please be aware of potential phishing scams imitating Amylyx. All authentic communications from Amylyx will be from the Amylyx.com domain.
