Senior Associate, Clinical Programming
Location: South San Francisco, California, United States
The Clinical Programmer is responsible for coordinating, programming, analyzing, and evaluating clinical trials data, as well as assisting the study team to ensure the quality of clinical trials data.
This person will work in tandem with Biostatistics and Data Management team members on various clinical projects including CRF and non-CRF data cleaning, building data checks, converting and normalizing external datasets, designing and generating data visualization reports of clinical study data.
Key Responsibilities include:
- Extract clinical data from the clinical data management systems to produce standard and custom data visualization reports
- Develop transfer specifications with vendors for external/non-CRF data sources
- Identify, program and execute data consistency checks to ensure the completeness and accuracy of data contained in extracts and transfers
- Create data listings and reports for clinical data cleaning
- Develop applications for clinical programming infrastructure
- Create metric and tracking reports in excel and PDF formats for review by Data Management and Study Management Teams
- Understand and execute department, product and study-level macros and utilities
- Ensure compliance with FDA regulations, GCP, ICH guidelines
- Comply with company's policies and procedures
- Perform other duties as assigned
Preferred Qualifications include:
- Bachelor or master’s degree in Statistics, Mathematics or in a relevant scientific discipline
- 5+ years of relevant clinical experience in the pharmaceutical, biotech or CRO industries
- Excellent SAS data manipulation and analysis skills
- Solid knowledge of R and R/Shiny and SQL
- Working knowledge of Spotfire and Python
- Excellent attention to detail
- Ability to work effectively and successfully in a team environment
- Broad knowledge of drug development process
- Excellent communication and interpersonal skills
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving millions of lives around the world. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients. We are currently focused on the development of two intelligently designed, scientifically novel clinical platforms:
An HBV program intent on creating a new class of oral therapeutics to finally cure hepatitis B. Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field.
A Microbiome program of potentially life-changing oral live biotherapeutics to transform the treatment of an entire range of diseases linked to the microbiome. We believe our Microbiome platform represents a best in class approach, translating naturally evolved, bacteria-host pharmacological interactions into rationally selected, live oral biotherapeutics.
Assembly Bio has a strong balance sheet and is well-positioned to advance our innovative research and potential medicines in HBV-cure and the Microbiome. Headquartered in South San Francisco, CA, Assembly Bio also operates a microbiome manufacturing facility in Groton, CT, and has offices in China.
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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