Biostatistician Manager
At a glance
Manager-level Data Science role at Integrated Resources INC. Woodcliff Lake · contract.
Pay not stated Data Science salary
dataroles summary, based on the employer's posting.
What you'll do
- Shape clinical trial protocols and provide statistical input on forms, randomization, study oversight plans and review committee documents
- Prepare or assess analysis plans, trial tables and listings, data specifications, monitoring plans and clinical study reports
- Coordinate data quality work with clinical data managers, including form design, transfer rules, testing and study review meetings
- Lead statisticians and programming work across complex trials, checking SAS outputs and supporting post-hoc analyses and publications
- Guide study teams on trial design and development plans, oversee CRO work, and help improve biostatistics operations and procedures
What you bring
- A master's degree in biostatistics or statistics plus eight years in pharma, CRO or biotech, or a doctorate with five years
- Strong SAS programming ability and prior oncology experience
- Experience handling multiple projects, with sound organization and judgment under deadline pressure
Who this fits
This manager-level contract role is onsite in Woodcliff Lake. It suits a biostatistician prepared to lead complex oncology trials, direct team problem-solving and manage day-to-day biostatistics work.
From the employer
At Mindlance, we strive to deliver value through the combination of right people, processes, technologies and program management solutions. Our methods include- applying domain expertise in specific industry segments, utilizing a highly-skilled workforce, leveraging a proven global delivery model, implementing structured and scalable quality processes and methodologies and yet, staying cost-effective
All in all, our expertise lies in providing trained and committed minds to help meet your business objectives, irrespective of the stage your business is in.
Contribute to clinical trial design, protocol concept sheet and protocol development
Participate study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc.
Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others
Work with clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality.
Oversee programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables. Perform post-hoc statistical analyses as needed.
May work on submission teams as a statistician and/or a programmer.
Generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies
Will serve as lead Statistician on complex trials and across multiple studies.
Project work including participating in the development of Clinical Development Plans (CDPs) and the protocol development process, developing and implementing Statistical Analysis Plans (SAPs), supervising CROs and interfacing with co-promoters, attending IPT meetings, consulting with clinical or regulatory affairs groups on strategic issues related to compound development, study designs, analysis, resource needs and future plans.
Managing non-project work including infrastructure development initiatives and involvement in committees working to develop SOPs and SWPs to improve quality, efficiency and timeliness of work processes.
Facilitate teams to identify issues related to biostatistics and propose solutions; manage day-to-day biostatistics operations and help to develop resource allocation to execute biostatistics initiatives as needed.
QUALIFICATIONS:
⦁ Must have a MS in Biostatistics/Statistics with at least 8 years of experience or a PhD in Biostatistics/ Statistics with at least 5 years of experience in the pharmaceutical, CRO or biotech industry.
⦁ Strong SAS programming skills.
⦁ Oncology experience is required.
⦁ Ability to effectively work on multiple projects
⦁ Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality.
⦁ Applies good judgment and leads problem solving within the team
⦁ Familiar with oncology clinical trial Phase I-III design and survival analysis, submission experience will be plus.
Thanks & Regards,
Pooja Mishra,
| Team Recruitment | Mindlance, Inc. | W: 732-243-0715
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