Sr. SDTM Programmer

Location
Sunnyvale, CA
Posted
Jun 23, 2018
Ref
2429
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

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.
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