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