Mgr, Statistical Programming
Woodcliff Lake, NJ
- Sets objectives, delivers results and implements policies and operational targets that have a direct impact on the work unit or operational outcome.
- Work may include policy changes or recommendations.
- Individual contributor with specialized knowledge.
- Has an easily discernible impact on the job area and expected results.
- Typically no cost center budget management responsibility.
- Executes work procedures in a project context. Consistently exercises judgment and discretion within generally defined procedures.
- Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments.
- Called upon to develop solutions utilizing creativity and ingenuity.
Presents concepts, facts, and reports to mid-level internal and external clients to advise of key trends and issues.
Contact with clients and external vendors and troubleshooting routine client inquiries. May represent the organization as a prime contact for technical matters of significant complexity.
- Directs the activity of a work team project within the department. May have responsibility for management of highly skilled professional employees.
- Work is completed under limited supervision.
- Typically reports to an Associate Director or above.
- Reviews SAP, TLG shells and variable derivation rules and provides feedback.
- Reviews Study Quality Surveillance Plan and Data Monitoring Committee charter.
- Implements the monitoring plan set by the statistician and produces the needed datasets and TLGs.
CLINICAL STUDY REPORT/INTEGRATION:
- Reviews the SAP, provides feedback to the statistician and develops (with the statistician) study specific datasets.
- Develops programs for the creation and validation of datasets (SDTM & ADaM) and TLGs.
- Integrates multiple studies in support of an ISS/ ISE.
- Supports ad-hoc, interim, exploratory, publications and performs programming and generates outputs.
- Maintains data, programs and reports in accordance with 21 CFR part 11.
- Creates / validates the eSubmission components (transport datasets for both SDTM & ADaM, Annotated CRF, define documents)
- Makes recommendations for improving resources (tools, systems, vendors, etc.) needed by the team.
- Manages the workflow of others to ensure work is done within a given deadline.
- May manage contractors and ensure that contractors, consultants and vendors complete assigned work according to agreed timelines.
- Tracks the expenses of work teams to anticipate cost issues.
- Manages the use of financial standards, guidelines and compliance for more informed and empowered decisions.
- May assist the review of 3rd party (contractors, consultants and vendors) work product and deliverables to recommend approval of payment of invoices or escalates issues when appropriate.
MATRIX AND TEAM MANAGEMENT
- Provides feedback, sets clear tasks and objectives and coaches team members on a periodic basis.
- May support employees by providing input into recruitment, selection, performance, succession, and transition activities.
- Trains team members on processes and / or systems.
PEOPLE MANAGEMENT(if assigned direct reports)
- Manages individual contributors
- Manages all employee-related activities throughout the year, including performance management and development.
- Identifies and communicates the skills, behaviors and experiences required to develop employees.
- Sets goals, reviews performance and provides feedback on a regular basis.
- Assists or Leads training of junior staff.
QUALIFICATIONS AND EXPERIENCE-
- BS or MS in Relevant Field
- Experience in clinical development statistical programming methods and processes in industry setting required.
- Foundational proficiency in statistical analysis.
- Intermediate proficiency in statistical programming.
- Foundational proficiency in regulatory process for biostatistics.
- Foundational proficiency in business knowledge.
- Foundational proficiency in therapeutic area knowledge.
- Foundational proficiency in regulatory knowledge.
- Foundational proficiency in project and resource management.
- Must be able to problem solve - plan - make timely decisions - delegate - set priorities - manage conflicts - possess interpersonal savvy - composure - and presentation skills.
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Eisai is an Equal Opportunity Employer Minority / Female / Disability / Vet