Manager / Senior Manager Statistical Programming - San Carlos, CA | Biospace
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Manager / Senior Manager Statistical Programming

Iovance Biotherapeutics, Inc.

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Location:
San Carlos, CA
Posted Date:
9/14/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Manager, Programmer, Statistics,

Job Description


Overview

Reporting to the Director, Statistical Programming, The Manager/Senior Manager, Statistical Programming, will be responsible for hands-on statistical programming activities for clinical and non-clinical data. This includes, but is not limited to, programmatic generation and documentation of tabulation and analysis datasets (per the CDISC standard) and final deliverables (TFLs) to be included in regulatory filings, CSR, and publications.

Specific Responsibilities

•   Deliver accurate and reliable programming results, ensuring that validation policies and required documentation accompany all generated datasets and results.  
•   QC validation of programming generated by vendor(s) and/or contractors to support final deliverables.
•   Build and maintain program directories with required documents to pass any future regulatory audits.
•   Provide high quality and accurate analysis outputs and supporting datasets that are delivered on time   whether for production or validation programming.
•   Ensure all statistical programming activities are conducted in accordance with GCP, internal SOPs and meet all regulatory requirements.
•   Recommend technical solutions that can be used or developed to increase efficiency of project work, may assist Clinical Data Management for generating the database report and comprehensive review listings.
•   Debug and resolve issues related to other programmers' code during validation.
•   Develop efficient SAS macros and communicate issues with system macros to Director, Statistical Programming.
•   Develop, modify and complete specifications for both SDTM & ADaM datasets per the CDISC guidelines.
•   Review TFL mocks and provide appropriate feedback promptly. Add programming instructions to improve the mock document and reduce potential errors.
•   As applicable, provide oversight in the activities of internal and/or external SAS contractors.

Requirements


Education and Qualifications

•   BS or MS in relevant field with minimum 5+ years relevant experience in the pharmaceutical or biotechnology industries.
•   Must have knowledge of FDA/ICH guidelines.
•   Comprehensive knowledge of Base SAS, SAS/GRAPH, SAS/ODS, and SAS/STAT required.
•   Good working knowledge of statistical analysis plans including the mockup tables, graphs, and data listings.
•   Must have experience implementing CDISC standards with hand-on programming and QC of SDTM and ADaM.
•   Prior experience in providing programmatic support for interim analysis, clinical study report and/or publications required.
•   Ability to form good working relationships with other employees in various functional groups within and outside the Biometrics department. Ability to work both independently and in a cross-functional team environment.
•   Ability to adhere to timelines and communicate proactively for any potential deviations from the timelines.
•   Good written, verbal communication and relationship skills including experience with managing external vendors and/or programming contractors.
•   Knowledge of data from oncology clinical trials and derivation of analysis populations is a plus.
•   Must be open to learn additional advanced SAS languages, clinical study designs, and CDISC requirements.