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Launched in 1986, Ockham is a global oncology CRO and full-spectrum global resourcing company. Clinical expertise, therapeutic focus, and successful oncology trial outcomes have created an industry leadership position for Ockham Oncology. Ockham Source continues to achieve success by offering traditional sourcing solutions as well as a growing FSP (Functional Service Provider). Ockham's world headquarters is based in Cary, North Carolina, with the European headquarters located in Roslin, Scotland, near Edinburgh. Ockham offices are located strategically around the world to serve global customers.
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Ockham is a global provider of resources to the Biotechnology and Pharmaceutical Industry. We work with companies involved with clinical trials and other market approval processes to help them deliver their products on time and on budget. One of our clients is looking for Biostatistics Manager / Senior Biostatistics Manager these are Home Based. These are contract positions.
Biostatistics Manager: •Provide statistical contributions, statistical review and quality control of Study Concept Documents (SCDs), protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications •Complete statistical analysis of individual studies/projects •Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings) •Be familiar with statistical policy and strategy •Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field •Communicate the role of the Global Biostatistics department, and may contribute to statistical training within Global Biostatistics and within Company •Assist in the review of Company Policies, SOPs and other controlled documents •Assist with study and systems audits conducted by Company CQA and external bodies •Team member of change / process improvement initiatives
Senior Biostatistics Manager: •Implement, oversee and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis •Plan and execute statistical contributions to Study Concept Documents (SCDs), protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph ( TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, product plans (e.g. Global Development Plan), Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), regulatory documents, reimbursement documents and other communications •Complete statistical analysis of multiple studies/projects •Hire, manage and develop statistical staff •Contribute to resource and budget planning •Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings) •Be familiar with statistical policy and strategy •Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field •Promote and communicate statistical awareness and the role of the Global Biostatistics department, and may contribute to statistical consultancy, statistical training and expert advice within Global Biostatistics •Lead and/or participate in the development and review of Company Policies, SOPs and other controlled documents •Participate in study and systems audits conducted by Company CQA and external bodies, and respond to audit questions and findings •May lead and/or participate in change / process improvement initiatives •May participate in external activities (e.g., Industry, academic)
Basic Qualifications: •Masters degree in Statistics/Biostatistics or other subject with high statistical content, and 3 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Or
•Doctoral degree in Statistics/Biostatistics or other subject with high statistical content •Communication of statistical information (written and oral) •Demonstrated effective communication skills (written and oral)
Senior Basic Qualifications: •Masters degree in Statistics/Biostatistics or other subject with high statistical content, and 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Or
•Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 3 years of post-graduate statistical experience in the pharmaceutical industry or medical research •Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia •Demonstrated ability to provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements •Demonstrated ability in presenting results and defending statistical findings, study design and analysis. This could be to internal audiences (study/product team) or at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings •Demonstrated effective communication skills (written and oral)
Preferred Qualifications: •Designing, analyzing and/or reporting clinical trials within Pharmaceutical / Biotechnology / Public Health setting in Industry, Government or Academia •Life-Cycle Drug Development experience (Pre-clinical Development, Clinical Development, or Post-marketing) •Leadership of at least 1 study/project with minimal oversight •Authored a protocol, DRT/DMC, SAP, CSR, or Research Project Plan (RPP) •Fundamentals of Project Planning
Senior Preferred Qualifications: •Demonstrated ability in presenting results and defending statistical findings, study design and analysis to internal audiences (study/product team) and at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings •Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing) •Statistical contributions to regulatory and/or reimbursement submissions •Demonstrated ability to influence decision making •Project Planning and Project Management •Development of policies and SOPs Keywords: SAS, SAS Programmer, Statistics, Statistical Programmer, Statistical Analysis, ISS/ISE, Biostatistician, Biostatistical Programmer, Clinical Trials, Clinical Research, Clinical Studies, Pharmaceuticals, Drug Development, IND, NDA, Data Management, Data Manager, Clinical Data Manager, Clinical Data Coordinator, Drug Safety, Drug Safety Specialist, Drug Safety Associate, Pharmacovigilence, Drug Safety Nurse, Drug Safety Physician, Medical Writer, Medical Writing, Regulatory Affairs, Regulatory Submissions, Clinical Project Manager, Clinical Trials Specialist, Medical Services Specialist, BSN, RN, Clinical Research Associate, CRA, Clinical Study Manager, Clinical Study Monitor, Clinical Trials Monitoring, Regional CRA, Regional Clinical Research Associate, In-house CRA, In-house Clinical Research Associate, CDISC, SDTM, ADaM, Rave, Medidata, InForm, Home based, telecommuting, ASG, Ockham
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| Company: |
Ockham |
| Base Pay: |
N/A |
| Other Pay: |
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| Employee Type: |
Contractor |
| Industry: |
Biotechnology Pharmaceutical |
| Manages Others: |
No |
| Job Type: |
Biotech Pharmaceutical |
| Required Education: |
4 Year Degree |
| Required Experience: |
Not Specified |
| Required Travel: |
Not Specified |
| Relocation Covered: |
Not Specified |
| Reference ID: |
5444 & 5445 |
| Location: |
Nationwide
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| Contact: |
Not Available |
| Phone: |
Not Available |
| Email: |
Send Email Now |
| Fax: |
Not Available |
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