Associate Director, Biostatistics (dg)
Clark Davis Associates (Northern New Jersey, New Jersey)

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Associate Director, Biostatistics (dg)

Major Pharmaceutical Firm, North NJ. 

Base salary of $125,000 to $154,000 depending on experience plus annual bonus, excellent benefits and long term incentives. 

Description:

Our client is currently seeking an Associate Director, Biostatistics.  This position will be with the Medical Affairs group.

You will be responsible for assigning and directing biostatistical resources for both clinical research and health outcomes research projects; prioritize work and provide direction to contracted resources; review documents for appropriateness of methods; negotiate with internal colleagues when demand exceeds team capacity; develop performance metrics for department; and oversee selection and annual evaluation of outside vendors and CROs.

Responsibilities:

-In this role you will lead the biostatistics and the medical affairs team for data management to ensure appropriate support for all Phase IIIb and Phase IV studies, as well as data mining projects.

-Ensure that study design, protocol preparation, and statistical analysis methodologies meet study and project objectives, and are in compliance with regulatory guidance.

-Collaborate with the development division biometrics colleagues to ensure worldwide organizational acceptance of statistical design and analyses.

-Ensure accuracy of all completed statistical analyses and interpretation in clinical study reports and adhere to timelines for deliverables on all projects.

-Direct and manage CROs in the provision of biostatistics and data management support for all assigned projects consistent with timeline expectations.

-Ensure the consistency of study designs, parameter algorithms and definitions, analyses and calculations, and reporting formats for all projects.

-Actively participate in strategic discussions with therapeutic teams and regularly interact with department senior management, CROs, and outside vendors.

-Address specific statistical issues in propose study design and write and defend the “Method of Analysis” section of submissions.

-5% travel is required for this position.

Education & Other Requirements:

-To qualify for this role you must have a MS in Statistics, Biostatistics, or Mathematics with 10-12 years of pharmaceutical industry experience or a PhD in Statistics, Biostatistics, or Mathematics with 8-10 years pharmaceutical industry.

-Must have full knowledge of advanced statistical analytical methods, clinical trial research, regulatory requirements, programming skills, and statistical software.

-Extensive experience analyzing clinical trial data and experience managing external CRO resources.

-Excellent oral and written communication skills; project planning skills; budgeting skills; demonstrated experience in analyzing clinical trial data; priority setting skills; multi-tasking skills; problem solving skills; eye for detail; exercise good judgment; and work well within team framework.

-A demonstrated mastery of advanced statistical analytical methods, clinical trial search, regulatory requirements; coding techniques, protocol development and personal computing is also required.

-Must have a green card or be a US citizen to apply for this opening. 

Please send your resume in Word format Darren Gutowski at dgutowski@clarkdavis.com; CLARK DAVIS ASSOCIATES, 5 Century Drive, Parsippany, NJ, 07054; Phone (973) 267-5511; Fax (973) 267-0232

For a list of over 200 job opportunities, visit our web site at www.clarkdavis.com