Overview

Pharmapace, Inc. ("Pharmapace") is a consulting and contract Clinical Research Organization ("CRO") founded by a group of veteran leaders in the biotech/pharmaceutical industry who are recognized experts in their respective fields. Pharmapace's core mission is to deliver exceptional value to biotech/pharmaceutical companies by providing high-quality consulting and outsourcing services to support our customer's clinical trials, regulatory submissions, medical affairs, safety surveillance, and outcomes research programs to help patients afflicted with a wide range of disease conditions.

The primary responsibilities of this position will be to lead programming activities for clinical studies. Provide extensive technical expertise as part of the Clinical and Statistical Programming (CSP) team to develop, test, maintain, validate, and document programs to meet business needs. Work within general programming standards and procedures to independently conduct statistical programming projects. Provide support to the development of project-related solutions to the full scope of database and statistical programming tasks.

Responsibilities

• Play leading role in study by managing and overseeing SAS programming activities from different aspects (programming aspect, statistical aspect and clinical trial aspect) to ensure SAS programming activities to follow regulatory and company standards.
• Ensure high-efficient, high-quality and timely deliverables with limited oversight.
• Contribute to the preparation, execution, reporting and documentation of SAS programming within several therapeutic areas.
• Create, manage, and maintain the SAS programming algorithm for the clinical study database and data analysis, and contribute to development and quality control of the clinical and statistical programming deliverables.
• Responsible for peer review of the submission packages and contribute to the input of SAP and mock TFLs.
• Perform ad hoc analyses with flexible and rapid programming arising from questions generated from planned analyses and results to support Phase I to IV clinical trials and medical publications.
• Maintain efficient interfaces with internal and external customers and vendors with support of the collaborating statisticians.
• May contribute to the creation and maintenance of company tools or department SOPs related to clinical data analysis.
• May mentor junior analysts/programmers.

Qualifications

Education

• Bachelor's or above degree in statistics/biostatistics or computer sciences.

Experience

• Minimum 5 years of experience in the pharma/biotech industry for Bachelor's and 3 years for Master's or be able to perform the essential job functions, (or otherwise qualified by training or experience).

Skills

• Advanced SAS programming skills (e.g., SAS SQL, SAS Macro, SAS/STAT, SAS/GRAPH, etc.) with clinical trial data.
• Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.
• Advanced clinical trial knowledge preferred, and knowledge of at least one therapeutic area.
• Advanced knowledge in industry standards, such as the ICH guidelines, CDISC standards, 21 CFR Part 11, and FDA guidelines.
• Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, EDC, eDT, SDTM, and in providing outputs to meet downstream requirements, e.g., ADaM, define.xml and TFLs.
• Excellent organizational skills, time management, and ability to lead SAS programming activities, coordinate workload, and meet established deadlines.

Anticipated base pay range: $76,910 to $141,270

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability