VirtualVocations

Offsite Principal Statistical Programmer

Kendle, named "Top CRO to Work With" in the Thomson CenterWatch 2007 survey and "Best CRO" for 2007 and 2006 by a leading global pharmaceutical publication, is a leading global clinical research organization providing the full range

of early- to late-stage clinical development services for the world's biopharmaceutical industry. Kendle has a 27-year history of serving customers, both large and small, and with a diversity of compounds. We are one of the fastest-growing global providers of Phase I-IV services offering experience spanning 90 countries.

We offer:
Competitive Compensation
Flexible work hours
Telecommuting opportunities
3 weeks paid time off annually
Company paid sick time
Tuition Reimbursement programs
401K plan with company match

Core Responsibilities

As a Principal Statistical Programmer you will be a vital part of the programming team, responsible for management of Statistical Programming projects at the local Kendle office as required by the sponsor. You will also perform the following duties:

  For assigned projects, accountable for ensuring that the local Statistical Programming department meets timelines, complies with contractual project requirements, and conducts projects within budget

  Participates in project teams as the Biometrics project leader by leading the Kendle team for Clinical Data Management (CDM), Database Programming, Statistical Programming, and Biostatistics

  Negotiates and establishes accurate time estimates for completion of project programming activities with internal team members and Statistical Programming management as well as ensures that project programming activities are completed within the allotted timeframe

  Plans, directs and/or implements all programming components of assigned projects, as required by the sponsor

  Routinely meets with Lead Programmers for assigned projects to evaluate and develop solutions for budgets, contract issues, timelines, and resources for projects

  Assists the lead programmer to work in concert with Project Leaders, Clinical Data Managers, Database programmers, and Biostatisticians to routinely measure project activities against budget to ensure operations are within budget constraints and to assist in review of project profit margins, and follows-through on changes in project scope or recommend project improvements.

  Monitors the quality of programs, specifications, and other programming work products as well as ensures that sponsors are provided with high quality deliverables

  Coordinates and participates in the processing of external data, the programming and validation of CRF and analysis datasets, tables, listings, and figures

  Assists in tracking project specific performance metrics

  Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload

  Assists management in prioritizing activities across local Statistical Programming projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals which promote teamwork and quickly restore department effectiveness

  Keeps staff aware of priorities across projects

  Maintains a good working knowledge of clinical drug development and programming in order to effectively serve as a department resource and train associates

  Mentors programming personnel through reviewing work and providing feedback or guiding new associates in processes

  Assists programmers in solving technical problems with effective, cost-efficient resolutions

  Develops training courses and presents training materials

  Promotes an environment in which associates demonstrate commitment to quality, professionalism, cooperation, and customer service; associates are encouraged to communicate ideas and opinions openly; and associates are able to exercise discretion and take reasonable risks

  Keeps management informed of decisions and issues which impact the department

  Provides timely and effective input to job performance reviews for other Kendle associates as required

  Assists and supports Statistical Programming sales and marketing efforts by participating at bid defense meetings or presenting sponsor proposals as requested

  May participate in the development of pricing estimates and descriptions of services for proposals

  Works cooperatively with other Kendle Biometrics personnel to establish SOPs, guidelines, policies, and/or procedures that promote standardization and efficiency across the Kendle Biometrics organization

  Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business

  Participates in sponsor audits as requested 

Qualifications:

  A master’s degree in mathematics, statistics or related field with 6 years experience in SAS programming and clinical trials experience is required. Also acceptable is a minimum of seven years experience with two of those years in project or administrative management in SAS programming in clinical trials.

  Candidate/incumbent will demonstrate superior organizational and verbal communication skills.

  Candidate/incumbent will interact with internal staff and sponsors across multiple departments and levels working in a team environment.

  Candidate/incumbent will have a working knowledge of English.

  Candidate/incumbent will have superior aptitude for logic and leadership, and will be driven to succeed.

Telecommuting may be an option for qualified candidates.

Kendle International is an Equal Opportunity Employer.

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Employer Posted:Wednesday, August 27, 2008