SAS/Biostatistician oppertunities in MA
From sasCommunity
We have several new Statistician/Biostatistician openings with our direct Clients and I’d like to run by you to see you might be interested. If any of these openings interest you please email me at neil.mahapatra@vernascientific.com with your contact number and good time for me to reach you. If you're not looking at the moment, but will be in the near future please let me know, so I can touch base with you when you are ready. If you know any of your friends looking for a Position please forward this email to them. Don't forget about our excellent "Referral Policy"! Great way to earn some extra cash for your vacation plans! We also have fulltime Perm and contract positions with Astrazeneca, Abbott, Genentech, Novartis, Cephalon, Sanofi-Aventis, J & J, Allergan, Merck and others. Positions in MA
Position: PRINCIAL BIOSTATISTICIAN Location: Lexington, MA Duration: FTE
Position Summary: Provides statistical support for clinical projects. Works under limited supervision to independently identify and initiate projects and tasks, and determine courses of action necessary to achieve departmental and corporate objectives, in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs). Duties & Responsibilities: · As an active member of the development project team, develop statistical strategy for assigned clinical programs; collaborate with the biostatistics team to meet corporate goals and objectives · Provide input to the department budget and resources for assigned projects · Actively participate in the development of SOPs, policies, departmental standards and other process improvement efforts vInteract with management across functional areas to set priorities and timelines. · Provide statistical training to statisticians and non-statisticians and mentor biostatistics associates on statistical methods, procedures and strategies · Oversee biostatistical and programming activities of outsourcing partners/vendors · Ensure clinical trial protocols are in line with project objectives through critical input and review · Review and approve key study related documents produced by other functions (CRFs, database, data management plan) to ensure appropriate data are collected, coded and handled · Ensure SAPs are in line with project objectives and are consistent with project standards · Collaborate effectively with members of clinical project team to execute SAPs; coordinate activities within Biometrics to ensure project support · Accurately interpret and communicate clinical trial results orally or via written documents · Contribute statistical input on regulatory questions; represent client before regulatory bodies · Provide critical review to clinical study reports, integrated summary documents and external publications · Serve as back-up support for any required statistical function in the department Minimum Requirements: · MS in biostatistics or related field and 6+ years clinical research experience in pharma/biotech industry or · PhD in biostatistics or related field and 4+ years clinical research experience in pharma/ biotech industry · In-depth knowledge of statistical techniques for analysis of clinical trial data in the respective therapeutic area · Thorough knowledge of SAS procedures and clinical data processing, with emphasis on regulatory agency requirements for data reporting · Demonstrated leadership experience · Extensive knowledge of FDA/ICH regulations/guidelines; previous interaction with regulatory agencies on statistical issues · Excellent written, verbal, communication and presentation skills · Ability to work effectively in a team environment · Detail-oriented with excellent organizational and problem-solving skills Minimum Requirements: · PhD preferred · Experience of drug development in oncology or acute care · Previous experience in the preparation of CTD/NDA/BLA submissions
Position: Sr Biostatistician I Location: Lexington,MA Duration: FTE
Position Summary: Provides statistical support for clinical studies; works under moderate supervision to determine and develop approaches or solutions, in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs). Duties & Responsibilities: · Collaborate effectively with members of clinical project team to execute SAPs · Participate in validation and/or programming of analyses · Provide statistical input to address regulatory questions · Participate in the development of SOPs, policies, departmental standards and other process improvement efforts · Interface with outsourcing partners/vendors for biostatistical and programming activities · Remain current with statistical methodologies and industry practices through regular attendance at conferences, training sessions, and/or other continuing education forums · Other duties as assigned Minimum Requirements: · MS in biostatistics or related field and 2+ years clinical research experience in pharma/biotech industry or PhD in biostatistics or related field and 1 year clinical research experience in pharma/biotech industry · Knowledge of statistical techniques for analysis of clinical trial data · Working knowledge of SAS procedures and clinical data processing with emphasis on regulatory agency requirements for data reporting · Familiar with FDA/ICH regulations/guidelines · Excellent written, verbal and interpersonal communication skills · Good organizational and analytical skills, with ability to multi-task and prioritize work · Ability to effectively work in a team setting Desired: · PhD preferred · Pharmaceutical, biotech, or regulatory area experience
Position: Sr Biostatistician II Location: Lexington,MA Duration: FTE
Position Summary: Provides statistical support for clinical studies; works under general direction to independently identify problems; develops and implements approaches or solutions in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs). Duties & Responsibilities: · May serve as lead statistician on development project team · Collaborate effectively with members of clinical project team to execute SAPs; coordinate activities within Biometrics to ensure project support · Participate in validation and/or programming of analyses · Provide statistical input to address regulatory questions · Participate in development of SOPs, policies, departmental standards and other process improvement efforts · Provide guidance to SAS programmers and other statisticians · Oversee outsourcing partners/vendors for biostatistical and programming activities · Other duties as assigned Minimum Requirements: · MS in biostatistics or related field and 4+ years clinical research experience in pharma/biotech industry or PhD in biostatistics or related field and 2+ years clinical research experience in pharma/biotech industry · In-depth knowledge of statistical techniques for analysis of clinical trial data · Demonstrated knowledge of SAS procedures and clinical data processing with emphasis on regulatory agency requirements for data reporting · In-depth knowledge of FDA/ICH regulations/guidelines · Excellent written, verbal and interpersonal communication skills · Superior organizational and analytical skills, with ability to multi-task and prioritize work · Ability to effectively work in a team setting Desired: · PhD preferred · Pharmaceutical, biotech, or regulatory area experience · Experience with drug development in oncology or acute care
Position: Sr Manager Biostatistician Location: Lexington,MA Duration: FTE
Position Summary: Manages the biostatistics activities and resources for assigned therapeutic area(s), in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs). Duties & Responsibilities: · As an active member of the project team, develop statistical strategy for assigned clinical programs; manage the activities of the biostatistics team to meet corporate goals and objectives; develop project and department standards to ensure consistency · Collaborate with management across functional areas to set priorities and timelines · Assess, select, and manage contract research organizations (CROs) and/or contract resources · Provide expert critical review of clinical trial protocols to ensure alignment with project objectives · Ensure SAPs are in line with project objectives and consistent with project standards · Coordinate activities within Biometrics to ensure project support · Contribute expert statistical input on regulatory questions; represent client before regulatory bodies · Provide expert critical review to clinical study reports, integrated summary documents and external publications · Serve as back-up support for any required statistical function in the department · Other duties as assigned Minimum Requirements: · MS in biostatistics or related field and 8+ years clinical research experience in pharma/biotech industry or · PhD in biostatistics or related field and 6+ years clinical research experience in pharma/ biotech industry · 1+ years of biostatistics management experience · In-depth knowledge of statistical techniques for analysis of clinical trial data in multiple therapeutic areas · Thorough knowledge of SAS procedures and clinical data processing with emphasis on regulatory agency requirements for data reporting · Extensive knowledge of FDA/ICH regulations/guidelines; previous interaction with regulatory agencies on statistical issues · Previous experience in the preparation of CTD/NDA/BLA submissions · Excellent written and verbal communication skills and interpersonal skills Desired: · PhD preferred · Education in Biostatistics, Applied Statistics, or related field · Experience of drug development in oncology or acute care
Position: Sr Statistical Programmers Location: Lexington,MA Duration: FTE
Position Summary: With minimal supervision, programs, tests and documents SAS programs which create tables, listings and figures for the summarization of clinical trial data, in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs). Duties & Responsibilities: · Assist in the preparation of the regulatory submission-ready packages · Assist in creating specifications for the integration of data from multiple studies · Conduct programming and documentation for integrated summaries and regulatory submissions · May serve as the statistical programming function lead on clinical project teams · Contribute to SOP development and process improvement efforts · May mentor/train other team members in departmental procedures and developing technical expertise · Follow good programming practices and adequately document programs · Create and maintain file structures for storing clinical data · Other duties as assigned Minimum Requirements: · BS or equivalent. Major in math, statistics or computer science preferred · At least 5 years relevant work experience or equivalent (biotech or pharmaceutical preferred) · Excellent knowledge of SAS Macro, SAS/SQL, SAS/GRAPH and sound knowledge of SAS/STAT · Comprehension of CDISC requirements · Strong understanding of regulatory requirements · Practical experience with regulatory data summarization · Knowledge of clinical trial development process · Familiar with medical coding dictionaries (WHO, COSTART, MedDRA ) · Ability to explain technical concepts clearly to non-technical colleagues · Excellent written, verbal and interpersonal communication skills · Strong organizational and analytical skills with ability to multi-task and prioritize work Desired: · Familiar with Oracle database applications
Neil Mahapatra *neil.mahapatra@vernascientific.com
Tel: ( 973-481-0100 Ext: 3020 F: 7 973-481-1020
Verna Scientific a Makro Company One Washington Park, Suite 1502, Newark, NJ 07102 Offices: Illinois, Pennsylvania www.vernascientific.com Verna, a full service Clinical/Scientific division of Makro, has been providing consulting services support to Pharmaceutical, Biotechnology and Medical Device industries for the past 10 years. Please ask us how to earn up to $2000 for referrals
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