Principal Statistical Programmers

Job Order ID:75
Employment Type:Permanent
Number of Positions:1
Job Location:Princeton New Jersey USA
Job Function:

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 Requirement:

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.   

 

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.

 

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.

 

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

 

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.

 

Provide and implement statistical programming solutions; ensure knowledge sharing.

 

Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications.

 

 

 

Number of associates:  

No direct reports (as assigned, coordination of at least 3 internal or external programmers)

Financial responsibility:

(Budget, Cost, Sales, etc.)

None

Impact on the organization:

 

1.      Timely, high quality and efficiently produced statistical programming deliverables included in study and projectlevel documents (incl. submissions)

2.      Reliable and compliant statistical analysis results presented externally (incl. submissions).  

3.      Innovative technical solutions to support timely and efficient drug development deliverables

 

 

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).