Lead, Statistical Programming
Company: Amylyx Pharmaceuticals
Posted on: June 24, 2022
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
- Effectively design and code SAS programs using BASE/SAS,
SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical
- Produce and deliver CDISC and regulatory compliant SDTM, and
ADaM standard datasets including datasets specifications for
- 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
- Provide programming support for building integrated summary of
safety/efficacy datasets and analysis.
- Provide programming support for ad hoc analyses and data
- 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
- 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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