Job Description:

Senior Statistical Programmer

Job Location

US-PA-Philadelphia | US-NY-Rochester

Overview

In the Senior Statistical Programmer role at ERT you will create, test and maintain SAS codes used to create CDISC compliant datasets for the cardiac safety statistical analysis; create and maintain procedures for creation of ADaM datasets; create electronic submission packages for cardiac safety submissions. Participate in process improvement for SAS programming and mentoring of new employees

ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so thatcustomers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience,ERT balances knowledge of what works with a vision for what's next, so we can adapt without compromisingstandards.

Powered by the company's EXPERT technology platform, ERT's solutions enhance trial oversight, enable siteoptimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuringpatient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies.Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more thanthree million patients to date. By identifying trial risks before they become problems, ERT enables customersto bring clinical treatments to patients quickly - and with confidence.

Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Support statistical programming activities for assigned Cardiac safety studies
1. Creation of dataset specifications as per study requirements.


2. Perform any and all functions as required to meet corporate commitments and deliverables; in particular, to creating codes for statistical datasets through SAS as well as reviewing and creating the electronic submission deliverables for sponsor submission.


3. Create and maintain SAS codes for analysis datasets, which includes programming analysis specific flags and other specifications per the Statistical analysis plan.


4. Create submission ready datasets for cardiac safety trials (SDTM EG and ADaM ADEG) in coordination with the client, internal statistics and data management teams while being compliant with CDISC standards.


5. Maintain working knowledge of CDISC standards and recommend changes to processes and standard specifications as needed.


6. Create define.xml and dataset reviewers guide for FDA submissions with reference to the datasets created for statistical analysis. Assist statisticians in preparation of Tables Listings and Figures for cardiac safety studies.

OTHER DUTIES AND RESPONSIBILITIES:

1. Assist with orientation and training of members of the statistics team, Systems Analysts and Data Management personnel as determined by management.


2. In conjunction with the entire department, recommend, develop and implement SOPs for improved procedures within the Statistics group.

The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. ERT reserves the right to amend or change this job description to meet the needs of ERT. This job description and any attachments do not constitute or represent a contract.

Qualifications

QUALIFICATIONS AND SKILLS NEEDED:

Education:

• BS in computer sciences, Engineering, Statistics or Mathematics.

Skills:

• Ability to work effectively in teams, effectively operates within a matrix organization and with multi-disciplinary groups,


• Excellent team player with strong interpersonal skills contributing to building the team spirit


• Ability to understand and anticipate the needs of customers, and respond to their inquiries


• Ability to organize team work and prioritize and balance concurrent tasks and responsibilities.


• Excellent time management skills

Experience:

• Experience with CDISC SDTM and ADaM standards.


• Minimum of 5 years' experience in SAS products and procedures in pharmaceutical or life sciences setting preferred


• Understanding of the pharmaceutical drug development process, as gained through a minimum of two years' experience in the pharmaceutical or healthcare industry.


• Strong organization, analytical and communication skills.


• Detail-oriented.


• Experience with Windows and Microsoft Office products.


• Experience with TFLs generation is a plus.

The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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