Sr. Statistical Programmer - FSP - US West Coast Only
Thermo Fisher ScientificSalary not specified
Full Time
Senior (5 to 8 years)
Associate Director, Statistical Programming at Dyno Therapeutics
Waltham, Massachusetts, United States
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
BiotechnologyIndustries
Requirements
- Bachelor’s or advanced degree in statistics
Responsibilities
- Lead and manage the statistical programming activities for clinical trials and studies, ensuring high-quality deliverables and adherence to timelines
- Oversee program specific statistical programming activities and vendor-related activities in clinical development
- Maintain programming infrastructure and ensure compliance with SOPs to produce quality and timely deliverables
- Collaborate with biostatisticians, data managers, and cross-functional stakeholders to define programming strategies, requirements, process optimization, and innovation for clinical development
- Serve as the program team point person for statistical programming and data standards, providing consultation to program teams
- Build a statistical programming team to support the Dyne clinical portfolio
- Assist the Head of Statistical Programming in contributing to departmental strategies and driving development/continuous improvement of departmental procedures, training, and standards
- Develop, validate, and maintain analysis datasets (CDISC standards), tables, listings, and figures (TLFs) in accordance with regulatory guidelines and internal standards
- Review statistical analysis plans (SAPs) to provide feedback and strategy to the team to execute the plans
- Perform complex statistical analyses and simulations using SAS and R to support clinical trial design and data interpretation
- Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD)
- Build and maintain software agnostic solutions/macros to automate repetitive tasks
- Provide novel solutions to the Biometrics and cross-functional teams to better understand the data
- Mentor and provide guidance to junior programmers, ensuring their growth and development within the team
- Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis
Skills
SAS
R
CDISC
TLFs
SAPs
eCTD
Dyno Therapeutics
Develops AI-optimized gene therapy vectors
About Dyno Therapeutics
Dyno Therapeutics focuses on advancing gene therapy by utilizing Artificial Intelligence to create Adeno-associated virus (AAV) vectors. These vectors are essential tools for delivering genetic material into cells, which is crucial for effective gene therapy. The company's AI technology enables the design and optimization of these vectors, potentially enhancing the success of gene therapies. Dyno collaborates with major pharmaceutical and biotech companies, such as Astellas, Roche, Sarepta, and Novartis, to develop therapies for various diseases affecting the skeletal and cardiac muscles, central nervous system, liver, and eyes. Unlike many competitors, Dyno's unique approach leverages AI to improve the performance of AAV vectors, setting it apart in the biotech field. The company's goal is to improve gene therapy outcomes through its advanced vector technology, ultimately benefiting patients with serious health conditions.
Watertown, MassachusettsHeadquarters
2018Year Founded
$106MTotal Funding
SERIES_ACompany Stage
AI & Machine Learning, Biotechnology, HealthcareIndustries
51-200Employees