Statistical Programmer
Lindus Health70,000 - 90,000 USD/year
- Full Time
- Mid-level (3 to 4 years)
$148,000 – $190,000Compensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, Biotechnology, CROIndustries
Requirements
Candidates must possess a Bachelor’s or Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field, and a minimum of 10 years of experience in statistical programming within the pharmaceutical, biotechnology, or CRO industries. Proficiency in SAS/Base, SAS/Macro, SAS/SQL, and SAS/Graph is required, along with strong experience with CDISC standards (SDTM and ADaM) and familiarity with define.xml and Pinnacle 21, as well as experience supporting regulatory submissions to FDA and/or EMA.
Responsibilities
The Principal Statistical Programmer will lead the design, development, validation, and maintenance of SAS programs for generating SDTM, ADaM, and TLFs, ensuring compliance with CDISC standards, FDA/EMA guidelines, and internal SOPs. They will collaborate closely with Biostatisticians, Data Managers, and Clinical Operations teams to define programming requirements, perform quality control and peer review of deliverables, act as a technical subject matter expert, support the preparation of clinical study reports and regulatory submission packages, and contribute to the development of departmental processes and vendor oversight.
Skills
SAS programming
CDISC standards
SDTM
ADaM
TLFs
Regulatory guidelines
Clinical trial processes
Quality control
Peer review
Clinical study reports
Regulatory submission
eCTD
ISS/ISE
Vendor oversight
Data science
Machine learning
Axsome Therapeutics Inc
Develops therapies for CNS disorders
About Axsome Therapeutics Inc
Axsome Therapeutics develops therapies for central nervous system (CNS) disorders, focusing on conditions like major depressive disorder, treatment-resistant depression, and Alzheimer's agitation. Their main product, AXS-05, is an oral medication that works by blocking NMDA receptors in the brain, which helps regulate mood. This drug has shown positive results in clinical trials and has received special FDA status to speed up its approval process. Unlike many competitors, Axsome emphasizes addressing unmet medical needs in CNS disorders and aims to improve patient outcomes through rigorous research and development. The company's goal is to bring effective treatments to market, enhancing the quality of life for patients suffering from these conditions.
Key Metrics
New York City, New YorkHeadquarters
2012Year Founded
$430.7MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
201-500Employees