- $252,470.00 -252,470.00/year*
8 Dorchester Rd
** Ascent Life Sciences is seeking a?Director of Biostatistics?for a permanent opportunity in Woodcliff Lake, NJ.? Apply by clicking the link below for immediate consideration or reach Alicia Licht at 323.###.#### with questions or for more information **
This position serves a critical role within the clinical development in that he/she will be responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating TLGs and analysis datasets and coauthoring manuscripts. In addition, this position would work with statisticians on process development, internal contractor oversight, and various team management and development tasks.
1. Reviews protocols and other study documents that are developed in collaborations of business alliances. Leads and oversees interactions with respect to statistical discussions. Provides statistical supports for regulatory submissions in the collaborations.
2. Provides statistical supports for clinical trials and drug development plans within the clinical development. Works with the clinical, project management, and data manager teams on strategic designs of studies; develops, reviews and/or approves study documents such as clinical study protocols, statistical analysis plan, CRF, edit check specification, data management plan, final database validations, final study report. Performs statistical analyses.
3. Influences the proper use of statistics throughout the?oncology business group; contributes to the development of departmental standards and guidelines.
4. Works with the internal/CRO statisticians and programmers to ensure the quality of CRO deliverables and on QA of data outputs.
5. Functions as lead statistician in global registration trials and manages all related statistical activities.
6. Leads and oversees preparations of inputs for regulatory documents and meetings with health authorities. Leads preparation of responses to health authorities including identification and execution of new analysis required for responses.
7. Comprehensively assesses options and analytical strategies and identify team training needs and recommends solutions
8. Provides strategic input and supports exploration of methods to improve Biostatistics operational efficiency
? PhD with 10+ years or MS with 15+ years of experience required in related discipline or in the pharmaceutical industry/CRO environment.
? Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process.
? Experience with CRO oversight and FDA submission preferred.
? Excellent technical writing and verbal communication skills.
? Strong teamwork ability/commitment and individual initiative.
? Strong organizational skills with ability to effectively manage multiple studies.
? Excellent programming skills in SAS or R.
MUST HAVES: Completed MS or PhD, strong employee management skills and strong statistical technical skills.
Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.
If you are ready to propel your career to new heights read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.
Associated topics: bioinformatics, biometrics, biostatistics, data analyst, data science, sas, statistics
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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