Senior Statistical Programmer

Job Order ID:74
Employment Type:Permanent
Number of Positions:1
Job Location:Princeton New Jersey USA
Job Function:

The Senior Statistical Programmer is responsible for all statistical programming aspects of   1-2 studies or assigned project-level activities. The position is a key contributor with biostatistics in ensuring that pharmaceutical drug-development plans in Oncology are executed efficiently with timely and high quality deliverables.   

Job Requirement:

  1. Lead statistical programming activities as Trial Programmer for 1-2 studies or assigned projectlevel activities. If assigned to cross-project aligned group (e.g. Standards), manage at least one, macro/utility function or local project.
  2. Co-ordinate activities of all programmers either internally or externally (FSP, CRO) assigned to the study/studies. Make statistical programming recommendations at study 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), 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, review and develop programming specifications as part of the analysis plans.
  6. Provide input into statistical programming solutions and/or ensure their efficient implementation.
  7. 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
  8. If assigned to cross-project aligned group (e.g. Standards), be responsible for an end-to-end development of a macro or utility function, or at least one local project under supervision.
  9. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
  10. Maintain up-to-date knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml), attend functional meetings and trainings.

 

Key Performance Indicators

 

  1. Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers, including the Clinical Trial Team, Lead/Trial Statistician and the operational manager.
  2. Adequate representation of the Statistical Programming function as Trial Programmer in the Clinical Trial Team, Data Review Team and BDM Project Team – effectiveness of communication and team behaviors as assessed by the team members.
  3. Ability and effectiveness in training, mentoring and coordinating internal and external programmers assigned to the same study as assessed by the operational manager.

 

Job Dimensions

 

Number of associates:  

No direct reports (as assigned, coordination of at least 1 internal or external programmer)

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  

2.      Reliable and compliant statistical analysis results presented externally.  

Ideal Background

 

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.

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

 

2.

Good 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.

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

 

6.

Proven ability to produce timely and quality deliverables under guidance (at least 1 year), preferably in Oncology  

 

7.

Ideally 3-4 years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry (2 years for MS Statistics/Computer Science graduates)