Senior Clinical SAS Programmer

Company : Katalyst Healthcares & Life Sciences

Country: United States

Location : Hayward, California

Post: Wed, 31 May 2023 06:40:18 GMT

Expires: Wed, 28 Jun 2023 23:59:59 GMT

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—————————— Job Description ——————————

Responsibilities:

Develop specifications, build and execute programs for internal data reviews, publications, exploratory, post-hoc and regulatory review.

Adopts strategic approach to producing and prioritizing analytical deliverables which includes study level or integrated analysis for safety signal detection or other business needs.

Work with data management to review case report forms, database specifications, and data transfer specifications

Manage on-time and quality delivery of CRO-generated analyses results.

Solid, demonstrated experience with CDASH and CDISC data standards (SDTM, ADaM) as well as health authority reporting requirements.

In-depth knowledge of data standards and demonstrated experience in the handling non-CRF data including proven ability to work with diverse data types.

Performs stakeholder management, negotiating timelines and scope of deliverables (helping to balance team and company needs with speed, rigor and clarity of message)

Provides leadership or project management to major data-heavy study or project team deliverables or initiatives.

Participate in standards governance and developing biometric department operational processes.

Requirements:

Bachelor or master’s degree in a data science field, e.g., statistics, mathematics, epidemiology, computer science, bioinformatics, or another field with commensurate levels of experience

Minimum 5+ years of biotechnology or pharmaceutical experience, with (immuno-) oncology experience preferred.

Programming experience in SAS a must. Experience working with other languages (R) in validated environments strongly preferred.

In-depth knowledge in the analysis of clinical trial data, including integrated analysis of clinical trial data with other data types (biomarker, PK/PD, real-world, etc.)

Experience managing delivery of statistical programming projects by CROs.

Demonstrated ability to rapidly adapt to changing project and strategic requirements.

Interest in continuing education, particularly in the areas of business knowledge as well as technology trends for producing analyses and visualizations (particularly with an eye towards reproducibility or interactivity)

Takes a fit-for-purpose mindset to daily work as well as long-term vision.