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NA0USA - Senior Principal Statistical Programmer - H201805SD - Princeton

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Active since 08-05-2018 Job category IT - Services & support
Location Princeton Level Professional
Educational level Bachelor / Graduate Employment type Permanent contract
Hours 0 Salary -
The Senior Principal Programmer is responsible for all statistical programming aspects of several studies, a large indication or project-level activities (incl. submission and post-marketing activities) and/or acts as technical expert on standardization/enhancement efforts. The position is a key collaborator and strategic partner with biostatistics in ensuring that pharmaceutical drug-development plans in Oncology are executed efficiently with timely and high quality deliverables.

Job Duties:


1. Lead statistical programming activities as Trial Programmer for at least 6 studies, indication, small project or project-level responsibilities (e.g. Submission / Safety coordinator, pooling of studies) or as Lead Programmer for project-level activities in large project(s) in Clinical Pharmacology (CP)/ Translational Clinical Oncology (TCO)/Global Medical Affairs (GMA). If assigned to cross-project aligned group (e.g. Standards), manage more than one global project and/or with strategic alignment with other groups/companies.

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 and propose strategies at study or project 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 or Submission/Safety team.

4. Review eCRF, discuss data structures and review activities as member of the Data Review Team, ensure project-level standardization which allows pooling and efficient CRT production.

5. Comply with company, department and CDISC standards and processes, assess and clarify additional programming requirements, review, develop and influence programming specifications as part of the analysis plans (incl. CSPD and other project-level strategies).


Education (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. Expert SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables, proven experience in development of advanced MACROs

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

3. Advanced 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. Proven communications and negotiation skills, ability to work well with others globally and influence.


 

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This listing is a full-time job

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

Contact information

Name Lana Krajnovic

Location

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