Senior Manager, Statistical Programming

Position Summary :

The Senior Manager, Statistical Programming is responsible for the organization of a statistical programming group that supports multiple drug development programs. The incumbent will manage a group of programmers who develop statistical programs that generate analysis datasets, produce outputs for tables and graphs, validate statistical programs, write general SAS application codes, prepare documentation for electronic submissions, and explore new methodologies to improve productivity of statistical programming.

Essential Duties & Responsibilities :

Collaborate with Programming Product lead and project leads in the resource planning, allocation and assignment of programmers. Address resourcing to adequately staff projects as needed.

Lead or contribute to departmental process and standards initiatives such as macro tools, innovation, CDISC standards implementation.

Contribute to the development and implementation of programming resource algorithm.

Oversee the work of internal and contract programmers, provide guidance, and mentoring to programmers in statistical programming methodologies. R esponsible for career development of all programmers in the team.

Contribute to the selection and management of CROs (including the strategic outsourcing providers) conducting statistical programming.

Oversee the work of staff in support of clinical trials, ad-hoc analysis requests, data validation, etc. in accordance with all relevant statistical regulatory guidance and standards.

Be a technical resource for programming group to provide advice on complex programming tasks and / or standards.

Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance (For all Supervising Managers)

Participate and support the development of TAUG (therapeutic area users guide) following CDISC Industry standards

Represent statistical programming in cross-functional teams and process improvement initiatives.

Contribute to department culture building and engagement

Other duties as assigned

Core Competencies, Knowledge and Skill Requirements :

PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Knowledge of SDTM and ADaM standards, able to write CDISC standard dataset specifications and follow specifications to create SDTM and ADaM datasets (as needed)

Computer programming using SAS

Fundamentals of project planning and management

Drug development process

Communication & Interpersonal Skills :

Excellent verbal and written communication skills

Ability to effectively collaborate in a dynamic environment

DESIRED BACKGROUND AND EXPERIENCE :

Experience leading teams supporting FDA / EMEA / CDE filings .

Solid knowledge and hands-on experience of CDISC standards such as CDASH, SDTM, and ADaM

Experience leading or working with centralized teams for Statistical Programming

Flexible to changing priorities, detail-oriented, works well under pressure with initiative to take on unfamiliar tasks.

Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction.

Demonstrated ability to accept responsibility for individual and team performance (accountability & ownership).

Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making).

Experience in development and implementation of statistical programming standards and procedures

Experience with the drug development process (pre-, early, late and / or observational) in related industries or academic research. Experience with oncology trials.

Expert level SAS programmer with experience in delivering complex programming assignments and analysis. Proficient in developing their own code as well as modifying existing code.

Education :

Master's degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject, or equivalent related experience

Experience :

Minimum 7+ years' clinical research and development programming experience using SAS

2+ years of demonstrated leadership experience

TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT (AS APPROPRIATE FOR THE POSITION)

Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)

Ability to work on a computer for extended periods of time.

Regularly required to sit for long periods of time, and occasionally stand and walk.

Regularly required to use hands to operate computer and other office equipment.

Close vision required for computer usage.

Occasionally required to stoop, kneel, climb and lift up to 20 pounds.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.