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Senior Statistical Programmer (Clinical Biopharma) - Simply Biotech

TalentZok in San Diego, CA, USA



Senior Statistical Programmer (Clinical Biopharma) - Simply Biotech

OVERVIEW

Are you looking for a new career opportunity with an exciting biopharmaceutical company focused on discovering, developing, and marketing innovative therapies for debilitating and often life-threatening diseases?! THEN READ ON! In the role, you’ll utilize a variety of analytic software to integrate PK drug concentration-time measures, pharmacodynamic responses, and clinical safety and efficacy information for PK/PD and Modeling and Simulation (M&S) analyses! Our client is offering top market compensation, generous bonus, excellent benefits, and RSUs! If this sounds good, let’s talk ASAP!

Immediate opening for a Senior Statistical Programmer at our client, an "essential business", located in San Diego, CA who possesses:

Bachelor’s degree in Statistics, Computer Science, Mathematics, Biology, Chemistry, Pharmaceutical Sciences, or a related technical discipline; MS preferred.

4+ years’ experience in clinical research, ideally as a programmer or analyst for phase I-III clinical trials in a pharmaceutical/CRO environment.

Technical knowledge of and experience with SDTM, ADaM, SEND, and Define.XML. Experience with PopPK or ClinPharm M&S is a plus.

Clear understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP).

Strong knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) and experience with MS Office are required. Experience with R or familiarity/experience with NONMEM, Phoenix, R, or SimCYP is a plus.

Email your resume to mturner@simplybiotech.com and call 858.356.6772

KEY RESPONSIBILITIES INCLUDE:

Under the supervision of the ClinPharm lead, deliver the PK/PD elements of the ClinPharm strategy.

Plan and generate analysis datasets (SDTM, ADaM, M&S, SEND), statistical tables, figures, and listings, along with supporting documentation, with specific focus on ClinPharm deliverables.

Provide statistical programming and validation support for clinical study reports and help coordinate programming activities with the ClinPharm lead, and Biometrics lead, and other study programmers to meet timelines.

Ensure quality of project programming deliverables.

Provide input on programming methodologies to support the clinical development process.

For immediate and confidential consideration, please email your resume to mturner@simplybiotech.com and call 858.356.6772

More information can be found at www.simplybiotech.com

Posted date: 28 days ago

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