Position: Sr. Director, Biostatistics
Location: North Carolina
Reference #: TL-11a-03
 (include reference number when responding)

** Email for quicker response**
Mike Sauer
(509) 951-8071
mike@landmarksearch.com

8-12 years of relevant experience in a CRO/Pharmaceutical company's Biostatistics Department including previous experience managing staff. 3+ years in CRO environment is desirable. Masters or PhD in Statistics or Biostatistics or related field. Familiarity with most complex statistical methods that apply to Phase I-IV clinical trials. Strong written, oral communication and presentation skills with excellent interpersonal skills. Previous experience managing. Department budget/financial tracking and Sales/proposal experience is desirable. Management style that delegates to and empowers employees, Demonstrated success of operation within senior/executive management teams and ability to represent site/department needs and issues to senior/executive management team. Interest in process improvement activities.

Seeking a Sr. Director, Biostatistics to head our Biostatistics department in NC. The Senior Director will serve as site head of the local Biostatistics department ensuring that target productivity (FTE, utilization, and output) levels are met. Manage an assigned group of high level staff/management from the Biostatistics and Statistical Programming sections. Manage direct personnel reports typically consisting of Manager to Director level staff from each function. Play major role in sales meetings and oversees departmental proposal preparation. Monitor budget and scope of within office projects and takes action necessary to maximize realization. Ensure that departmental staff contribute to intra- and interdepartmental process improvement to achieve "best practices". Ensure that Biostatistics is working as efficiently and effectively as possible with other departments. Ensure that appropriate levels of professional development and training are provided to staff. Serve as a biostatistical resource for the department, ensuring scientific integrity in the application of statistical methodology to clinical trials. Provide statistical direction, technical oversight, or consultancy for major projects or on projects involving particularly complex statistical analyses. Represent clients at FDA meetings, FDA advisory boards, or other scientific meetings as required. Fulfill a global role such as an executive client sponsor or working party lead.

Position: Senior Statistician
Location: Texas
Reference #: C0-11b-04(include reference number when responding)

** Email for quicker response**
Mike Sauer
(509) 951-8071
mike@landmarksearch.com

Duties and Responsibilities: As a member of the Biostatistics and Clinical Informatics team, the Sr. Statistician is responsible for determining appropriate statistical methodology and performing analyses on clinical and non-clinical trial data. Works closely with Clinical Affairs and Clinical Informatics personnel on Clinical Affairs projects. Also, may be required to provide statistical support to R&D engineering studies and Quality validation studies. Prepares Statistical Methods section of protocols; writes Statistical Analysis Plans; performs statistical analyses with minimal supervision and guidance. Writes and modifies SAS programs; validates programs used to analyze/list/summarize clinical safety and efficacy data for Clinical/R&D/Quality reports and product regulatory submissions. Understands how databases are organized and queried; supports database design/management efforts; extracts data from databases in various formats.

Minimum Qualifications/Education:

• PhD in statistics with at least two years experience in biostatistics and clinical studies, or MS degree in statistics with at least five years’ biostatistical experience in clinical studies
• Knowledgeable in general statistical theory and methods used in the Biomedical and Pharmaceutical industries
• Able to propose and defend study designs and statistical methodology
• Excellent SAS programming skills
• Familiar with database structures and applications
• Strong attention to detail
• Ability to work independently in performing statistical analyses of data
• Ability to work in a fast-paced, team-oriented environment; ability to multi-task
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Ability to interpret technical instructions and deal with abstract and concrete variables
• Ability to interpret results of data analyses to ensure validity of conclusions
• Ability to read, analyze, and interpret common scientific and technical journals
• Excellent interpersonal communication skills (written and verbal)
• Excellent time and resource management skills
• Substantial experience in a biostatistical group in the medical device or pharmaceutical industries, or with a CRO
• Prior experience in the design and analysis of clinical trials in the medical device industry

• Act as a representative of the biostatistics department on project teams
• Ensure adequacy of proposed study designs and statistical methodology
• Write statistical methodology sections of protocols
• Write formal Statistical Analysis Plans to be carried out in the analysis of clinical studies
• Perform statistical analyses of data and interpret results to ensure validity of conclusions
• Interact with data management personnel and/or CRO’s as necessary to ensure that datasets are in usable format; perform statistical diagnostics prior to database locking
• Collaborate with CRAs in the design of study analysis TLG mockups
• Interact with SAS Programmers to ensure that appropriate programs are being developed
• Perform statistical quality assurance review and program validation for each project.
• Interact with medical writers in production of statistical and integrated clinical/statistical reports and other documents containing statistical information. Review statistical sections of draft documents.
• Support Engineering and Quality departments when statistical support is solicited
• Write/modify SAS programs for purposes of listing, summarizing, and analyzing clinical study and non-clinical data
• Perform Monte Carlo simulations to determine power and sample size
• Supports database design/management efforts

Position: Biostatistician
Location: Minnesota
Reference #: BS-11b-01 (include reference number when responding)

** Email for quicker response**
Mike Sauer
(509) 951-8071
mike@landmarksearch.com

Duties and Responsibilities: Under limited supervision performs the following duties: Generates statistical summary tables, patient data listings, and reports using SAS. Performs quality control check of SAS programs. Handles moderately complex SAS programming issues as well as all other study programming issues. Provides input to database requirements and provides SAS data set specifications for EDC trials. Assists with UAT of data transfer files. Works with the Biostatistics Manager and Clinical Sciences staff to develop scientifically sound clinical study designs and contributes to the statistical section of clinical research protocols. Contributes to or prepares statistical analysis plans under the direction of the Biostatistics Manager. Prepares template and performs programming for periodic progress reports for assigned clinical programs. Compiles clinical data and relevant background material, and presents these results to the Biostatistics Manager for review.

Minimum Qualifications/Education: Master's level degree in biostatistics, statistics, or public health; Bachelor's level degree will be considered. At least 3 years of experience in SAS programming; preferably 2 years in medical device or pharmaceutical clinical trials. Demonstrated computer expertise in SAS programming and word processing; experience using SQL and EDC highly desirable. Familiarity with clinical trial design and analysis issues.

This position is responsible for biostatistical activities in support of clinical trials including: generating data tables, patient data listings and reports using SAS; preparing statistical analysis plans; contributing to the statistical section of clinical trial protocols; reviewing analysis of clinical trial data.

Position: Programmer/Biostatistician
Location: Colorado 
Reference #: LS-11b-02 (include reference number when responding)

** Email for quicker response**
Mike Sauer
(509) 951-8071
mike@landmarksearch.com

Duties and Responsibilities: Performs statistical analysis and programming for ongoing studies. Works independently with various departments on statistical analysis requests such as ad hoc requests from commercial, marketing and medical affairs. Performs exploratory analyses in reply to regulatory agencies and in preparation for Advisory Committee meetings. Develops and maintains plans outlining steps and time tables for developing programs. Converts designs and specifications into SAS code. Created test transactions and runs tests to find errors and confirms programs meet specifications. Compiles code into programs and correct errors detected. Creates programs using SAS language to support the clinical area, data management and regulatory submissions. Maintains and validates statistical programs to produce analysis data sets and TLGs. Maintains and validates statistical programs to process and merge external vendor data with CRF data.

Minimum Qualifications/Education: Requires a Masters degree in statistics or equivalent with a minimum of 2-5 years related experience and demonstrated working knowledge of scientific principles, software languages and computer systems.

The Programmer/Biostatistician will design, develop, evaluate and modify computer programs to analyze and evaluate clinical data. Recognize inconsistencies and initiate resolution of data problems. Typically creates programs using SAS language to support the clinical area. Implements data management plans designed to meet project and protocol deadlines, provides expertise in the design and development of clinical trials, protocols and case report forms. Acts as liaison between various departments such as clinical, medical affairs, marketing and biometrics, subcommittees and project teams on an as needed basis.