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Director of SAS Programming - Oncology

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Support, Oracle, Client, Unix

Projektbeschreibung

Essential Functions and Duties:

* Develop and maintain clinical trial data and statistical reporting standards in line with pharmaceutical industry standards, conventions, and regulatory requirements.
* Perform programming and validation of database acceptance checks, required datasets, and TFLs
* Provide leadership/expertise in day-to-day statistical programming in support of ongoing project.
* Develop and conduct training for statistical programmers, biostatisticians, and other internal personnel required to perform programming activities.
* Provide mentorship and supervision to programmers.
* Develop and provide expertise in other programming and system administration areas such as Unix, Oracle and MediData according to business needs.
* Serve as primary contact between divisional areas and the client for responsible areas.
* Build successful relationships and seamless interfaces at the protocol/project team level.
* Develop and monitor timelines for statistical programming activities for assigned projects.
* Coordinate project start-up activities, including project area set-up, creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
* Develop and/or validate SAS programs to generate complete, accurate, consistent and validated statistical output (eg, TFLs) of clinical trial data as specified in the Statistical Analysis Plan (SAP) as well as ad hoc analyses as requested
* Develop and/or validate SAS programs to generate analysis datasets following common standards, conventions, and statistical instructions.
* Develop and test SAS codes for clinical trial database logic checks.
* Document data and programming information in accordance with SOPs and guidelines.Review/develop CRF annotations and database data specifications
* Interface with data management and statistics to identify and program edit checks per the Data Validation Plan/Data Management Plan and study management reports
* Demonstrate strong SAS programming skills, participate in protocol team and some project team interactions. Provide timely and effective communication to the statistical leads.
* Understand regulatory requirements concerning industry technical standards (e.g., CDISC standards, 21 CFR Part 11, FDA requirements, electronic submission standards, etc.) and implications for the department
* Lead the effort to establish, implement and enforce SOPs, guidelines, and procedures for programming activities, including review of sponsors' requirements and SOPs.
* Develop SAS macros, templates and utilities for reporting and data cleaning.
* Assist the VP developing templates for TLF mock-shell development, derived dataset specifications, programming specifications, and other process supporting documents.
* Assist the VP in planning, directing, and managing the programming group, including performance reviews and development plans for direct subordinates.

Required Education:

Minimum of Bachelors Degree in Information Management, Computer Science, Mathematics, Statistics, or a scientific discipline. Masters degree in statistics/biostatistics is preferred.

Required experience: Experience in Biostatistical Analysis and SAS Programming for clinical trials in the pharmaceutical or biotechnology industry. The candidate must have a minimum of ten years of programming experience in a clinical trials environment.

If interested, please send along an updated CV for review

To find out more about Real Staffing please visit www.realstaffing.com

Projektdetails

  • Einsatzort:

    San Francisco, California, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland