Senior Principal Statistical Programmer

Job Order ID:73
Employment Type:Permanent
Number of Positions:1
Job Location:Princeton New Jersey USA
Job Function:

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 Requirement:

  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).
  6. Provide and implement statistical programming solutions; ensure knowledge sharing. Act as programming expert in problem-solving aspects and training of new applications/processes.
  7. Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/project.
  8. If assigned to cross-project aligned group (e.g. Standards), be responsible for the end-to-end development of more than one global project and/or collaboration with GenMeds/NIBR on standardization efforts or technical system enhancements.
  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 advanced knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml), attend functional meetings and trainings.
  11. Act as subject matter expert (SME) or participate in process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures.

 

Key Performance Indicators  

 

  1. Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers, including the International Clinical Team (ICT)/Submission or Safety Team, Program Statistician and the operational manager.
  2. Adequate representation of the Statistical Programming function as Trial/Lead Programmer in the Clinical Trial Team/ICT, Data Review Team and BDM Project Team or Program Programmer/Submission/ Safety coordinator in project-level meetings – effectiveness of communication and team behaviors as assessed by the team member
  3. Ability and effectiveness in training, mentoring and coordinating internal and external programmers assigned to the same study/project as assessed by the operational manager.
  4. Ability and effectiveness as a programming representative on non-clinical initiatives.

 



Job Dimensions  

 

Number of associates:

As assigned, coordination of at least 3 internal or external programmers, and/or first managerial role with direct reports.

Financial responsibility:

(Budget, Cost, Sales, etc.)

None

Impact on the organization:

1.      Timely, high quality and efficiently produced statistical programming deliverables included in regulatory submissions, publications and marketing promotions

2.      Reliable and compliant statistical analysis results presented externally.

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

4.      Efficient team organization and environment

 

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.       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.

6.       If assigned to cross-project aligned group, proven ability to review/assess programming applications/software and/or contribute to standardization efforts

7.       Experience as Trial/Lead Programmer for several studies or project-level activities, preferably in Oncology, including coordination of team of internal or external programmers on a given study/project, ability to transfer own knowledge to others

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