Senior Biostatistician (Massachusetts)

This position provides statistical input into Phase II, III and IV clinical trial development, performs the analysis of clinical trial data, and provides statistical input into the reporting of clinical trial results. Provides statistical input into protocol/CRF development in all therapeutic areas at Company (e.g., trial design, sample size estimation, randomization, statistical methods for protocols, query checks for clinical trial data). Write detailed statistical analysis plans for clinical trials as well as for integrated summaries of efficacy and safety. Analyze clinical trial data producing accurate results representing the outcome of the trial. Validate statistical output. Accurately interpret and clearly communicate statistical results and concepts to non-statisticians. Co-author final integrated reports of clinical trial data writing thorough and clear statistical methods sections and producing the statistical appendix for the reports. Provide statistical output as required for manuscripts and ensure that the results are accurately interpreted in the publications. Provide input into statistical SOPs and general standardization efforts within the department (e.g. statistical methodology standards, standard data presentations. Participate in interactions with regulatory agencies as required. Collaborate effectively with members of clinical trial implementation teams and with Biometrics colleagues.

Requirements: PhD with 3-5 years of Pharmaceutical/Biotechnology experience

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Associate Director, Biostatistics (Massachusetts)

We have a key management opportunity for an experienced Associate Director for Biostatistics. You will oversee the development and evaluation of analysis plans and directs statistical analysis for four registry programs in a post-approval setting while managing several other people within the Biostatistics department. The candidate will be the statistical leader of the registries group, responsible for meeting both regulatory and marketing objectives within the programs; providing innovative statistical methods and analyses that will have high visibility and impact within the company. The ideal candidate will establish and maintain direction of the biostatistics organization through strategic planning, coach and supervise staff in project decision making, and oversee the design, development, modification and evaluation of a technical infrastructure.

Requirements: Ideal candidates should have Ph.D. in Biostatistics or Epidemiology with at least 5 years of experience or Masters Degree with at least 8-10 years of experience and strong technical skills. The successful candidate will have strong quantitative skills, including longitudinal data analysis and statistical programming with a preference given to SAS. Successful staff management experience with collaborative communication and interpersonal skills is required.

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Associate Director, Biostatistics (NJ)

Responsible as a lead statistician. Participate/support development of clinical program. Review protocols & case report forms for soundness of trial design. Write statistical methodology section of the protocol. Prepare analysis plan and programming specifications. Perform inferential analyses. Write the statistical section of the clinical trial report and review clinical trial report. Support/participate in drug project related activities including preparation of global HA submissions. Oversee CRO deliverables for trials contracted out. This position is for Company Pharmaceuticals Corporation

MS in Statistics with at least 9 years of pharmaceutical experience or PhD in Statistics with at least 5 years of pharmaceutical experience. Strong statistical and data analysis skills; knowledge of clinical trial methodology. Solid hands-on experience as a lead statistician in clinical development program. Solid experience in supporting NDA submissions. Strong ability in protocol development, analyses and clinical trial reports/publications for Phase II-IV clinical trials. Good knowledge of drug development process. Very good oral and written communication skills. Knowledge of FDA/ICH guidelines. Good knowledge of SAS computer package. Good project management

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Associate Director, Biostatistics (NJ)

Apply pharmacokinetic/pharmacodynamic (PK/PD) modeling, population pharmacokinetic modeling, physiological modeling, clinical trial simulation, and related techniques in support of early clinical development (until Proof-of-Concept) and full clinical development (until submission to Health Authorities). Provide support at the trial level with regard to study design, analysis, and reporting. Provide support at the project level with regard to the elaboration and implementation of the PK/PD concept for the project, strategic decision making based on modeling and computational input, and preparation of NDA integrated summaries of clinical pharmacology, effectiveness, and safety. Support project statisticians and pharmacokineticists with regard to modeling and related activities. Support or interact with the Methodology Group in areas of expertise. May participate in/or lead non-clinical projects activities (e.g. development of global standard procedures, application of new modeling methods and related computational aspects).

Master’s Degree in a modeling-related field with at least 9 years of related experience, or Ph.D. in a modeling-related field with at least 5 years of related experience.

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Statistician (Europe with excellent global relocation)-Several positions

Be responsible for all statistical tasks on the assigned clinical trials, e.g., clinical trial design/planning, analysis plan, reporting activities, exploratory analyses and additional analyses to support publications, and statistical consultation during the running phase. Track clinical trial activities and milestones. Ensure timeliness and adequate quality of all deliverables for the assigned trials. Follow processes and adhere to company and project specific standards as well as Health Authority requirements (SOPs, NIPs, Master Analysis Plan, GCP, and regulatory guidelines). . Establish and maintain sound working relationships and effective communication within the clinical trial team and the team. Participate in non-clinical project activities as needed.

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Senior Statistician (Europe with excellent global relocation)-Several positions

Be responsible for all statistical tasks on the assigned clinical trials, and perform these tasks with a high level of independence: clinical trial design/planning, analysis plan, reporting activities including exploratory analyses and additional analyses to support publications, plus statistical consultation during the running phase. May be assigned to lead a small project or parts (e.g. indication) of a project, initially under the guidance of a more experienced statistician, but with increasing autonomy and accountability. Track clinical trial/allocated project activities and milestones. Ensure timeliness and adequate quality of all deliverables for the assigned trials and project tasks. Follow processes and adhere to company and project specific standards as well as Health Authority requirements (SOPs, NIPs, Master Analysis Plan, GCP, and regula-tory guidelines). Participate in or lead non-clinical project activities as needed. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team/International Clinical Team and the team.

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Expert Statistician (Europe with excellent global relocation)-Several positions

Be the statistical leader and project manager for all deliverables globally for a clinical development program, or a mega trial. Ensure that clinical development program (or parts assigned) meets scientific, reg-latory, quality, and commercialization requirements, through interaction with the IPT and ICT. Perform matrix management of team, and mentor staff as required. Ensure modeling and simulation contribution is fully integrated into the project. Plan and track project level activities, including resources. Establish and maintain project standards (master analysis plan, full development project specifications). Plan and manage submission activities, like SCS, SCE, briefing books. Participate in/lead non-clinical project activities. Interact with Health Authorities and external consultants as appropriate. Support and defend analyses and their interpretation at Health Authority Meetings. Represent Biostatistics at FDA Advisory Committee meetings. Could take Trial Statistician responsibility as appropriate.

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Senior Expert Statistician (Europe with excellent global relocation)-Several positions

Be the independent statistical leader and project manager for all deliverables globally for a large and technically complex clinical development program, including supervisory functions like appraisals of full-time team members. Ensure that clinical development program meets scientific, regulatory, quality and commercialization requirements, through interaction with the IPT and ICT (e.g., drive CDP and TPP development from a statistical perspective). Be a scientific leader/expert within a Therapeutic area, showing leadership/be the point of reference in statistical methods, regulatory guidelines, project strategies, clinical development planning and study design in specific indications. Perform matrix management of project team, and mentor staff as required. Ensure quality of scientific contributions, integrating input from Biostatistics, Methodology, Modeling and Simulation and external experts. Initiate and drive innovation by implementing novel methods and innovative designs. Plan and track project level activities including resources. Establish and maintain project standards (master analysis plan, full development project specifications). Plan and manage submission activities, like SCS, SCE, briefing books. Participate in/lead non-clinical project activities. Interact with Health Authorities and external consultants as appropriate. Support and defend analyses and their interpretation at Health Authority Meetings. Take significant Biostatistics leadership role at FDA Advisory Committee meetings. Evaluate in licensing opportunities.

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Statistical Programmer (Europe with excellent global relocation)-Several positions

Provide input as required at all meetings, discussions and activities covering aspects of Statistical Reporting on trial level activities. As required, make certain that documents and specifications are consistent and comply with company standards by providing input into study protocol, CRF, data structures, specifications of analysis datasets, pooled datasets, listings, summaries, figures and tables for phase I – IV clinical trials. Program, according to specifications, analysis datasets, pooled datasets, listings, tables, and figures for phase I-IV clinical trials and for SCS and SCE. Track clinical trial milestones for SR deliverables. Maintain records for all assigned projects including archiving of trial analysis and associated documentation. Support senior members of SR and program statisticians in maintaining efficient interfaces with internal and external customers. Comply with pre-defined project / study standards and specifications. Support SR colleagues in non-clinical initiatives.

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Senior Statistical Programmer (Europe with excellent global relocation)-Several positions

Lead the programming activities for a trial, early phase project, indication, or publication activities; lead a complex/large project under supervision of a Program Statistician / Group Head. Maintain efficient interfaces with internal and external customers with support of SR management and the Program Statistician. Develop resource plans as required with support of the Group Head. Develop and comply with project / study standards and specifications following internal guidelines. Make certain that documents and specifications are consistent and comply with company standards by providing input into study protocol, CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities. Program, according to specifications, analysis datasets, pooled datasets, listings, tables, and figures for phase I-IV clinical trials and for SCS and SCE with high quality and within milestones. In consultation with the statistician, develop specifications for analysis datasets, pooled datasets, and listings. Support quality control and quality audit of deliverables. Maintain records for all assigned projects and archiving of trial / project analysis and associated documentation. Participate in the selection of CROs and supervise the SR trial activities of the CROs. Provide input on process improvement initiatives and participate in non-clinical project activities.

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Principle Statistical Programmer (Europe with excellent global relocation)-Several positions

Manage the programming activities for a global project following internal project management guidelines including resource planning. Act as Program Programmer for assigned projects and take a programming leadership role on the project team. Maintain efficient interfaces with internal and external customers with advice from SR management. Develop and comply with project / study standards and specifications following internal and regulatory guidelines. Oversee programming style, quality of SR contributions and compliance with timelines. Provide SR input and lead sections of Full Development and Submission Working Groups. Ensure that documents and specifications are consistent and comply with company standards by providing input into study protocol, CRF and data structures. Program, according to specifications, analysis datasets, pooled datasets, listings, summaries, figures and tables for phase I-IV clinical trials and for SCS and SCE. Ensure quality control and quality audit of deliverables. Maintain records for all assigned projects and archive trial / project analysis and associated documentation. Participate in the selection of CROs, as required, and supervise SR project activities for CROs. Train staff on trial and project level activities and internal processes. Participate in or lead non-clinical project activities.

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Senior Principle Statistical Programmer (Europe with excellent global relocation)-several positions

Act as independent Program Programmer for assigned projects, take a programming leadership role on the project team. Act as a deputy for Group Head on key projects. Maintain efficient interfaces with internal and external customers consulting SR management for high level strategic advice. Manage complex projects. Oversee programming style, quality of SR contributions and compliance with timelines. Develop and implement project / study standards and specifications for complex projects in compliance with internal and regulatory guidelines. Plan resources for key sub-areas within SR (e.g., TAs). Ensure that the study protocol and CRF are consistent and comply with company standards. Program analysis datasets, pooled datasets, listings, summaries, figures and tables for phase I-IV clinical trials and for SCS and SCE according to specifications. Participate in the selection of CROs and supervise SR activities for CROs. Keep up-to-date with state of the art programming techniques. Induct, supervise (matrix) and train programmers on programming skills, trial and project level activities, and internal processes.

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Expert Statistician, Clinical Pharmacology (Switzerland)-Various opportunities
This key individual will provide statistical support, strategic insight, operational guidance and coordination for assigned drug projects. To act as a member in the International Clinical Teams of clinical projects lead by Department; the tasks include statistical study design, especially for Proof of Concept studies, protocol preparation and the initiation of clinical trials, the statistical analyses and the preparation of the statistical sections for clinical trial reports and providing statistical input to documents in support of decision making. To contribute with innovative statistics which may involve the development of novel statistical procedures, the adaptation and implementation of a novel but existing procedure to a study or project and the implementation of new processes. In depth knowledge and expertise in statistics and its applications to clinical trials and their PK/PD parts. Solid knowledge of drug development process and HA guidelines especially in regard to Clinical Pharmacology and PK. Background medical and pharmacokinetics knowledge. Good working knowledge of statistical software packages. Good data exploration and modeling skills. Very good communication and presentation skills. Ability to give guidance to trial statisticians. Good team worker. Good business ethics. Fluent English, oral and written.

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Sr./Statistical Programmer (NJ)
The candidate will provide quality statistical programming support for clinical trials conducted for regulatory submission to government agencies; will work with and assist statisticians in the summary of clinical trial data for clinical trial reports, including summary tables, data listings and figures and assist in additional tasks as needed. BS or MS with a minimum of 5 years experience in industrial clinical trial experience. Good verbal and written communication skills, good interpersonal skills and proficiency with statistical software, particularly SAS, are essential.

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Biostatistician (NJ)
Reviewing protocols and case report forms for soundness of the clinical trial design; writing statistical methodology sections of the protocols; preparing statistical analysis plans and computer programs; collaborating with clinical research scientists, clinical research associates, clinical data managers and medical writers to provide statistical support for regulatory submission to government agencies; cleaning databases, analyzing data; writing/reviewing the statistical sections of clinical trial reports; presenting and defending statistical results to government agencies and assisting in additional tasks as needed. Ph.D. in Statistics or Biostatistics with 3-5 yrs of industry clinical trial experience. Excellent verbal and written communication skills, excellent interpersonal skills and proficiency with statistical software, particularly SAS, are essential. Knowledge of current U.S. and international regulatory requirements that relate to statistical considerations for IND/NDA is preferred.

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Associate Director, Biostatistics (multiple opportunities in CA, MA, NJ, NY, IL)
Associate Director, Prinicpal Biostatistican for clinical studies, including study design, protocol writing, statistical analysis plans and reports. Work closely with medical, sales marketing and investigators to produce regulatory submissions & publications. 5 plus years statistical experience in pharmaceutical or biotechnology industry. Excellent communication skills needed. MS or PhD in statistics/biostatistics.

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Associate Director, Biometrics (MA)
The Associate Director, Biometrics oversees all Biometrics activities to ensure successful completion of projects; provides statistical/technical guidance to the biostatistics staff, and programming/technical guidance to SAS Programmers; serves as primary point of contact for project managers, line managers, executive staff, and clients. Will also: direct the creation of analysis plans and specifications, validation protocols and reports, and statistical reports; ensure project completion is timely and according to guidelines; work interdepartmentally to define Biometrics timelines and resourcing needs; monitor timeline compliance across projects for analysis plans, logic checks, data entry audits, and analyses; develop SOPs and monitor compliance; develop budget proposals; collaborate inter-departmentally to define and solve operational issues; represent clients at FDA meetings; manage personnel activities; function as Lead Biostatistician on selected projects.

Qualifications: Ph.D. in Biostatistics or related discipline and 4 years of industry experience, or M.S. with a minimum of 9 years industry experience including 2 years in a CRO; minimum 3 years project and team management experience.

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Principal Biostatistician (MA, CA, NJ, NY, IL)
The Principal Biostatistician analyzes and interprets confidential data from a variety of sources, and provides senior statistical support and mentoring. Responsibilities include participating in the design and review of clinical protocols and case report forms including: preparation of Statistical Considerations sections, sample size calculations, interim looks, and study design recommendations; participating in database design, data collection guidelines, and computerized logic checks; creating analysis plans; generating and implementing prospective analysis validation plans; writing and reviewing statistical reports; designing and managing generation of randomization schedules; overseeing complex randomization designs; providing statistical expertise and support to clients and internal project team members; preparing and reviewing FDA statistical responses; providing expert guidance and training to Biometrics staff on statistical procedures, methods, and concepts; may serve as project manager for Biometrics stand alone studies.

Qualifications: Ph.D. in Biostatistics or related discipline and 3 years of industry experience, or M.S. with a minimum of 5 years industry experience.

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Epidemiologist (Midwest, NY, MA)
This position is responsible for providing input into pharmacoepidemiology study design for purposes of safety analysis; interface with epidemiology consultants regarding ad hoc safety questions. Will be responsible for assisting clinical trials groups in their needs for safety assessment of marketed drugs as well as drugs in development; Will be responsible to work with the clinical safety and postmarketing safety teams toward epidemiology comments on formal safety analyses. Requirements: MS/PhD in Epidemiology.

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Clinical Data Manager (MA)
Under direct supervision, the CDM I reviews data; assists in database design and testing; designs CRFs and guidelines; designs and tests logic checks; generate queries for missing or discrepant data; utilizes tools/systems to code medical terms and medications; works with Clinical Monitoring, Medical Affairs, Database Development, Biometrics and Project Management personnel to resolve project related issues.

Required Qualifications: Bachelor's degree or equivalent combination of education and experience. Must have a basic understanding of the clinical research development process and database design; a good understanding of the clinical data management process, physiology, pharmacology, and clinical study objectives and methodologies; good computer skills; good verbal and written communications skills; good problem-solving skills; must be detail-oriented.

Preferred Qualifications: 1+ years of clinical data management experience; experience in a CRO/pharmaceutical/biotech environment.

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Clinical Data Manager II (MA)
Under general supervision, the CDM II reviews data; assists in database design and testing; designs CRFs and guidelines; designs and tests logic checks; generate queries for missing or discrepant data; utilizes tools/systems to code medical terms and medications; interfaces with Clinical Monitoring, Medical Affairs, Database Development, Biometrics and Project Management personnel to resolve project related issues; provides clinical data management expertise to all aspects of the study. Serves as a resource to other Clinical Data Management staff and/or personnel and clients outside of the department.

Required Qualifications: Bachelor's degree or equivalent combination of education and experience. Minimum 3 years experience in clinical data management including some experience in a CRO/pharmaceutical/biotech environment. Must have a thorough understanding of: the clinical research development process; standard operating procedures; good clinical practices; the clinical data management process; physiology, pharmacology, clinical study objectives and methodologies.

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