SunnyvaleRecruiter
the smart solution for Sunnyvale jobs

Sr. SDTM Programmer

Company: Pharmacyclics, LLC
Location: Sunnyvale
Posted on: September 13, 2018

Job Description:

Sr. SDTM Programmer Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer. General Position Summary / Purpose: The Sr. SDTM Programmer position will assume CDISC SDTM data programming responsibilities for multiple studies. Major responsibilities include SAS programming activities to generate and/or validate SDTM datasets by reviewing annotated CRFs, mapping specifications, OpenCDISC issues, as well as by risk-based QC approaches. This role will also work with statisticians and SDTM vendors to ensure data completeness, correctness, and consistency according to Pharmacyclics standard. As needed, this role may also generate clinical programming deliverables to support data cleaning and monitoring activities, including data listings, edit checks, study metrics, reconciliation reports, dictionary coding files, and coded datasets used for statistical analysis. Key Accountabilities/Core Job Responsibilities: Programming (75%) Develop and/or validate SDTM datasets for statistical analysis and regulatory submission Develop and verify SAS programs/macros to generate data listings, edit checks, study metrics, and reconciliation reports Develop and verify SAS programs/macros to generate MedDRA/WHODrug dictionary coding files and coded datasets Support ad hoc and urgent programming tasks as assigned by management Communication (10%) Work with statisticians to clarify and document SDTM derivation logic in the mapping specifications Work with other statistical programmers to ensure consistent mapping specifications are applied across studies per Pharmacyclics convention Work with data managers to ensure data issues are communicated and addressed in a timely manner Standards (10%) Monitor CDISC and regulatory guidance regarding SDTM Implementation Perform impact assessment and change control for standard version upgrade Process (5%) Adhere to existing SOPs and work instructions Qualifications: Knowledge: CDISC SDTM standard MedDRA and WHODrug dictionaries FDA 21 CFR Part 11 guidelines Software Development Life Cycle (SDLC) Skills/Abilities: Base SAS and SAS Macro programming Windows operating system Microsoft Office applications Education Requirements (degree, certifications, etc.): Include must have and preferred BS/MS in Statistics, Math or Scientific Discipline. #LI-SH13 Equal Opportunity Employer Minorities/Women/Veterans/DisabledAssociated topics: .net, application architect, application developer, architect, architecture, backend, design, devops, software architect, software engineer lead

Keywords: Pharmacyclics, LLC, Sunnyvale , Sr. SDTM Programmer, IT / Software / Systems , Sunnyvale, California

Click here to apply!

Didn't find what you're looking for? Search again!


I'm looking for
in category
within


Other IT / Software / Systems Jobs


Earn 800-1200 Weekly as a Health Rep... Need a Computer and a Phone
Description: Get the Comprehensive full training and an excellent career path with our health care rep positions now available.
Company: Jumpstart consult
Location: Manteca
Posted on: 09/23/2018

Lead Software Engineer
Description: Let companies apply to you, not the other way around Sign up with Hired to get access to thousands of companies currently hiring engineers. Are you a Lead Software Engineer You will be responsible for (more...)
Company: Hired
Location: Redwood City
Posted on: 09/23/2018

Sr. Embedded Software Developer
Description: Job Responsibilities: ul li This person will participate in the development and maintenance of the existing and next generation product suite li The candidate will be responsible for the design, (more...)
Company: Fortinet
Location: San Jose
Posted on: 09/23/2018


Mobile Developer
Description: Let companies apply to you, not the
Company: Hired
Location: Port Costa
Posted on: 09/23/2018

Product Software Engineer
Description: Earnest empowers people with the financial capital they need to live better lives. br br We use technology, data, and design to: br ul br li Build more affordable products, br li Deliver (more...)
Company: Earnest
Location: San Francisco
Posted on: 09/23/2018

Staff Software Engineer, Core Technology Group (Data Engine)
Description: Staff Software Engineer, Core Technology Group Data Engine Our Company Everything Informatica does begins and ends with data. Simply stated, we make great data data that is connected, clean and safe (more...)
Company: Informatica
Location: Redwood City
Posted on: 09/23/2018

System Software Engineer
Description: We are now hiring a Senior System Software Engineer to join the Automotive System Software group focusing on Platform Diagnostics. This position will be part of a dynamic crew that builds and maintains (more...)
Company: NVIDIA
Location: Santa Clara
Posted on: 09/24/2018

Senior System Software Engineer - Cloud Networking
Description: We are looking for a Senior System Software Engineer, Cloud Networking Platform to design, implement and deploy scalable Software Defined Networking SDN solutions in NVIDIA NGN Cloud that drives NVIDIA's (more...)
Company: NVIDIA
Location: Santa Clara
Posted on: 09/23/2018

Lead Software Engineer
Description: Let companies apply to you, not the
Company: Hired
Location: Diablo
Posted on: 09/23/2018

Full-Stack Software Engineer
Description: Let companies apply to you, not the other
Company: Hired
Location: Bolinas
Posted on: 09/24/2018

Log In or Create An Account


Find us on Facebook

Find us on LinkedIn

Get the latest California jobs by following @recnetCA on Twitter!

Sunnyvale RSS job feeds