Wilmark Scientific

Assoc Dir/Director Biostatistics and Data Managem

Primary Responsibilities Summary: This position is responsible for the development of statistical analysis plans, including completion of statistical analysis for all product development activities. In addition this individual will have the vision to create a Biostatistical group with all that is needed to facilitate the development and implementation of statistical analysis plans for projects in development and products on the market. Department functions will include biostatistics, data management, SAS programming, and clinical systems. This individual must ensure that clinical data activities and processes are performed and are conducted according to company and sponsor requirements. This position ensures statistical integrity for the design of clinical trials and the development of protocols. Will be responsible for writing accurate, logical, clear, concise, and thoroughly planned statistical methods and analysis of clinical trial data. Responsibilities will also include the preparation of study analysis plans applying appropriate statistical methodology and determining the most appropriate data presentation in order to communicate results to intended audience. Coordinate and ensure the accuracy of clinical trial randomizations. Must be able to discuss statistical aspects of studies with investigators, medical directors, and regulatory authorities. Participate in the determination of project planning, resourcing, and timelines. Will be responsible for completing work within defined time frame-ensuring deadlines are met. Must keep abreast of statistical developments. Work effectively as a team player. Obtain familiarity with relevant clinical topics and issues.

Candidate Profiles: Ph.D. in Biostatistics/Statistics or closely related discipline required as well as a minimum 5 years of pharmaceutical/biotechnology experience required. Prior management experience necessary. Knowledge of current trends in statistical methodology and a thorough understanding of all phases of clinical trial also as well as a thorough knowledge of statistical theory and the ability to apply the theory in clinical trials also required. Must be capable of understanding the regulatory guidelines for the development of protocols and final reports. Experience in statistical computing, including SAS and PC-based systems a must. Strong problem-solving and interpersonal skills as well as excellent written, verbal, and organizational skills required. Individual will report to VP of Clinical Research and Clinical Affairs

Priscilla S. MacDowell
Wilmark Scientific
20 Williams Street
Wellesley, Massachusetts
(781)237-9981
Fax (781)237-5590