Lead, Statistical Programming
Company: Amylyx Pharmaceuticals
Location: Cambridge
Posted on: May 13, 2022
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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.ResponsibilitiesEffectively 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.RequirementsMS in Statistics, Computer Science, or a related
field with at least 6 years (or BS in Statistics, Computer Science,
or a related field with at least 8 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
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