Principal Statistical Programmers - Princeton

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Active since 07-05-2018 Job category IT - Services & support
Location Princeton Level Professional
Educational level Bachelor / Graduate Employment type Permanent contract
Hours 0 Salary -
Job Description:

The Principal Programmer is responsible for all statistical programming aspects of a large/pivotal study, several studies or project-level activities (incl. submission activities). The position is a key collaborator with biostatistics in ensuring that pharmaceutical drug-development plans in Oncology are executed efficiently with timely and high quality deliverables.

Job Requirements:

1. Lead statistical programming activities as Trial Programmer for either a large/pivotal study, at least 3 studies or Lead Programmer for project-level activities in Clinical Pharmacology (CP)/ Translational Clinical Oncology (TCO)/Global Medical Affairs (GMA). If assigned to cross-project aligned group (e.g. Standards), manage at least one global project.

2. Co-ordinate activities of at least 3 programmers either internally or externally (FSP, CRO), mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study level or project (CP, TCO, GMA) level.

3. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the Clinical Trial Team.

4. Review eCRF, discuss data structures and review activities as member of the Data Review Team.

5. Comply with company, department and CDISC standards and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans.

(minimum/desirable): BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field

Languages: Fluent English (oral and written).

Experience/Professional requirement:

1. Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables

2. Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications

3. Good knowledge of CDISC data structures as well as a solid understanding of the development and use of standard programs

4. Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, ICH) and clinical study practices, procedures and methodologies.

5. Good communications and negotiation skills, ability to work well with others globally.

6. Experience as Trial Programmer, preferably in Oncology, including coordination of internal or external programmers on a given study/project, ability to transfer own knowledge to others

7. Ideally 5+ years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry

More information
This listing is a full-time job

Job category IT - Services & support
Industry / Industries IT
Region United States

Contact information

Name Lana Krajnovic