Lead, Statistical Programming

Company: Amylyx Pharmaceuticals
Location: Cambridge
Posted on: June 24, 2022

Job Description:

Are you looking for a place where your work can have a deeper impact than you ever imagined-and where you can be true to yourself?At Amylyx, we're bringing together talented people like you who are committed to solving for humanity's most devastating diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer's disease, and others-all in a uniquely supportive, respectful environment that rewards innovative thinking, committed teamwork, and boundless curiosity.Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences-in all the best ways.We provide a competitive employee benefits package including stock options and RSUs; flexible work options including hybrid and remote; discretionary time-off; comprehensive healthcare, including dental and vision coverage; and retirement savings benefits.Position SummaryThe Lead Statistical Programming will be responsible for providing hands-on programming support and technical guidance on clinical trials and regulatory submissions. Reporting into the Head of Statistical Programming, 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. In this role 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.Requirements
  • MS in Statistics, Computer Science, or a related field with at least 8 years (or BS in Statistics, Computer Science, or a related field with at least 10 years) of SAS programming experience in the pharmaceutical or biotech industry.
  • Proficient in SAS programming.
  • 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).
  • In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
  • 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.COVID-19 Vaccination Policy: Candidates should be aware that Amylyx's current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company. Watch this inspirational video of how our Co-founders worked with Patheon and Thermo Fisher in the early days of starting Amylyx. To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIN. To return to our website please click here .Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. 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.

Keywords: Amylyx Pharmaceuticals, Cambridge , Lead, Statistical Programming, Other , Cambridge, Massachusetts