Principal Statistical Programmer

Manage and coordinate all statistical programming activities. May supervise statistical programmers in a line management or matrix capacity. Create, test and maintain SAS codes used to create CDISC compliant datasets for the cardiac safety statistical analysis; create and maintain procedures for creation of ADaM datasets; create electronic submission packages for cardiac safety submissions. Participate in process improvement for SAS programming and mentoring of new employees.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Produce and maintain submission ready datasets in support of cardiac safety trials (SDTM EG and ADaM ADEG)

• As applicable, manage one or more direct reports from statistical programming in a line or matrix capacity according to corporate policies and procedures; managing includes but is not limited to work allocation, resource management, professional development and goal setting/attainment.

• Develop, test and implement data standards in support of cardiac research and /or submission ready datasets for cardiac safety trials 

• Validate results of statistical analysis dataset by double programming 

• Support research programs and provide research results to the senior team resources and/or department management

• Identify, develop and create processes (macros, standard programs) for Cardiac Safety Department Deliverables

• Provide consultation on teleconferences with sponsors in support of regulatory bodies (FDA, EMEA, PMDA) with regarding to data and dataflow. 

• Train team members on standard operating procedures and standard methodology

• Develop process improvements to increase overall operational efficiency

• Drive ideas for future analyses and data quality efforts

• Provide creative solutions to problems under time constraints

• Provide guidance and support to junior staff

• Research and develop new programmatical techniques for the creation of statistical analysis datasets to drive industry recommendations

• Research and implement data processing techniques for new service lines

• Participate in Client discussions to communicate statistical programming activities in support of statistical analyses or regulatory requirements

• Work with cross-functional team to understand the scope of work for statistical deliverables at the project level 

• Manage timelines and client commitments and ensure on-time delivery for assigned projects 

• Inputs & maintains accurate deliverable status/dates, etc. team tracking tool

• Participates in hiring process

• Manages process workflow for team

• Accomplishes team results by communicating & managing job expectations; planning, monitoring, coaching & counseling of staff

• Conducts onboarding and training on statistical programming team/practices of staff

• Create and Implement Standards Consistent with industry 

• Assists with the development, coordination, maintenance & enforcement of quality standard compliance, including creating SOPs, SWIs, Playbook/Checklists and Templates for team deliverables

• Implements strategy for team

• Provides recommendations of strategic concepts

• Demonstrates proficiency in understanding of team procedures & content/application within team's deliverables and alignment across the organization

OTHER DUTIES AND RESPONSIBILITIES:

• Generate and interpret compliance checks on CDISC formatted analysis datasets (SDTM, ADaM).

• Create electronic submission packages (define.xml, reviewers guide, supportive documents) in support of cardiac safety trials and in accordance with regulatory FDA submissions guidelines.

• Leads team strategy meetings, and other departmental meetings as needed.

QUALIFICATIONS AND SKILLS NEEDED:

Education:

• Ph.D. 5 + Yrs Related industry experience 

• MS 7+ Yrs Related industry experience
   

Skills:

• Experience in clinical trials within a CRO or pharmaceutical research organization.

• Familiarity with Clinical protocols and Statistical Analysis Plans, understanding of the pharmaceutical drug development process.

• Experience with creation, testing and maintaining SAS codes used to create CDISC compliant datasets.

• Experience in SAS Programming.

• Excellent verbal and written communication skills.

• Experience in analyzing data.

• Experience with electronic submission packages with regulatory bodies.

• Experience CDISC SDTM and ADaM standards.

• Strong organization, analytical and communication skills.

• Experience with Windows and Microsoft Office products.

• Experience with TFLs generation is a plus.

• Ability to work in a group setting and independently, adjusting to rapidly changing priorities

Experience:

• Experience with CDISC SDTM and ADaM standards.

• Minimum of 9 years’ experience in SAS products and procedures in pharmaceutical or life sciences setting preferred.

• Understanding of the pharmaceutical drug development process, as gained through a minimum of two years’ experience in the pharmaceutical or healthcare industry.

• Strong organization, analytical and communication skills.

• Detail-oriented.

• Experience with Windows and Microsoft Office products.

• Experience with TFLs generation is a plus.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required.  Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract.

The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.