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Statistical Programmer

UNLIMITED HOLIDAYS - EXTRA HOLIDAYS - EXTRA PARENTAL LEAVE - LONG REMOTE PERIOD ALLOWED

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

United States

Offer summary

Qualifications:

Bachelor's or master's degree in biostatistics, computer science, or related fields., At least 6 years of relevant experience in the biotech or pharmaceutical industry., Proficient in SAS programming in a regulated clinical research environment..

Key responsabilities:

Generate SDTM and ADaM datasets, tables, listings, and figures for studies and regulatory agencies.
Review statistical analysis plans, CRFs, and study data-related documents.
Contribute to study reports, regulatory submissions, safety update reports.
Perform additional analysis/validation, collaborate with CRO statisticians.
Contribute to Biometrics SOPs, process improvement initiatives, and department infrastructure.

Katalyst HealthCares & Life Sciences Pharmaceuticals SME http://www.KatalystHLS.com

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Your missions

Responsibilities:

Provide statistical programming support to generate SDTM and ADaM datasets, tables, listings, and figures for individual studies and ISS/Client to FDA, EMA, and other worldwide regulatory agencies.
Participate in the review of statistical analysis plans and TLF specifications.
Review or annotate CRFs for SDTM mapping, review/author SDTM/ADaM dataset specifications.
Review, and comment on CRFs, vendor data transfer specifications (DTS), edit checks and other study data related documents.
Support in the preparation of study reports, regulatory submissions, and annual safety update reports
Perform additional analysis and validation for data checking, publication, presentation, poster and ad hoc analysis.
Work with CRO statistical programmers and perform statistical programming vendor oversight.
Contribute to Biometrics SOPs and work instructions related to EDC studies, FDA requests, and statistical programming processes.
Contribute to department process improvement initiatives.
Support department infrastructure build up by developing, validating and testing the macros, utilities and tools.
Keep abreast of literature and advancements in SAS.

Requirements:

Bachelor's or master's degree in biostatistics, computer science, or related fields, Master's degree preferred;
At least 6 years of relevant experience in the biotech or pharmaceutical industry.
The ideal candidate must be able to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
Proficient of SAS programming in a regulated clinical research environment
Experience of programming and validation of SDTM and ADaM data sets, tables, figures, and listings.