美国当地新增生物医药管理职位-202010

1. CMC Senior Director/VP (Dermatology formulation)- Shanghai/Chicago/Boston/home base

初创公司，专注在免疫和自体免疫领域

2. Biometrics, VP：Chicago/Boston

初创公司，专注在免疫和自体免疫领域

3. Biostatistics, Director/Senior Director-Boston

大型上市药企

4. Biostatistics, senior manager or associate Director-New York

大型上市药企

5. Biostatistics Programming, manager or senior-新泽西

大型上市药企

职位1）Role Purpose Statement:

This role is focused on Planning, solving and presenting pharmaceutical development work of CMC.

Main Accountabilities:

1. Serve as the CMC project leader for assigned Drug Products.

2. Lead the process development of monoclonal antibody/SME drugs, technology transfer, pilot amplification,

including development planning, management of the entire process of CMC Development, and ensure it align

with the overall project plan.

3. Maintain effective communication with internal and external responsible parties.

4. Define the CMC activities required for implementation of the product clinical/commercial plan, ensure

alignment with company’s overall business strategy.

5. Develop the Product Definition and CMC Strategy documents with appropriate input from cross-functional

team members

6. Monitor and control the CMC process; within budget, and timeline.

Role Related Qualifications/ Skills:

1. Previous experience in the development of topical Derm formulation

1. PhD. in life science disciplines and with more than 10~15 years of pharmaceutical/biotech industry experience

2. 10+ years of technical experience in one or more areas of Biologics CMC development and in charge of at

least one CMC project focusing on drug formulations .

3. Familiar with the latest regulations and rules of FDA, CFDA, EMA. Strong knowledge of Chinese CMC

regulations and guidelines including NDA and IND filing requirements.

4. Experience with Clinical-stage CMC development.

5. Strong working knowledge of GMP.

6. Experience with CMC technical content for regulatory submission is preferred.

7. Excellent communication skill on both oral and written, both in Chinese and English.

8. Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and

the ability to be creative and imaginative in the approach to new and diverse problem solving.

9. Global pharma experience a plus.

职位2： Role Purpose Statement:

Development and implementation of strategy, goals and policies for the Global Biometrics group and cross geographical (mainly US, China) in line with overall company strategy.

The incumbent is responsible for leading the Biometrics team to provide statistical leadership in design, analysis, and interpretation of clinical studies conducted and providing statistical input to clinical and management teams. Representing Statistics function in interactions with regulatory authorities on regulatory submission and regulatory defense. Providing strategic statistical inputs for go/no go decision, development plans and regulatory requirements for programs.

Main Accountabilities:

• To establish the Biometrics function (statistics, statistical programming and data management).

• To coach statisticians/statistical programmers/data managers assigned to the projects/studies.

• To stay updated on relevant statistical methodology and tools.

• Be aware and updated of any specific guidelines and/or practices most suitable to the health authority requirements to facilitate and accelerate the registration of Reistone products

• To build a network of statistical experts to facilitate the relationship with the Chinese Authorities (CFDA) and to participate in the agency meetings.

• Participate in, or initiate other tasks assigned, e.g. writing or updating SOPs.

• Contribute to clinical development programs & study designs for the development candidates.

• To coordinate evaluation and selection of qualified biometric CROs in China for outsourcing. To act as a project coordinator to ensure efficient CRO management and validation of statistical tasks of the clinical trials.

• Act as a trial-statistician (responsible for study design, statistical section of synopsis/protocol, statistical analysis plan, performing analyses, statistical reports, clinical study reports), if needed.

Role Related Qualifications/ Skills:

• PhD Degree in statistics/biostatistics.

• At least 10 years’ experience as a biostatistician in the pharmaceutical or CRO industry.

• Extensive experience in giving input to development plans, protocols, IND submissions, NDA preparations and FDA meetings

• Good knowledge on regulatory statistical guidelines

• Ability to communicate statistical issues to non-statisticians

• Ability to coach others, experience in training and developing SOPs& guidelines

职位3 Responsibilities:

• Responsible for the activities of bio-statistical sciences for the global( US/ex-China) clinical projects of the group

• Provides strategic leadership and vision to the building of the function, establish the bio-statistical system and develop the functional-level standards, SPs, and templates;

• Ensure that all the projects are correctly designed, properly analyzed and clearly presented to support new product development, regulatory submissions and the maintenance and growth of existing products

Project/Resource Management

• Monitor budgetary and resource needs, and manages CROs

• Improve the efficiency and standardization continuously

• Collaborate with the China part to develop the global clinical capability

• Provide relevant input into Business Development & Licensing assessments

Qualifications

• Ph.D. or M.S. in statistics, biostatistics, or related field

• At least 8 years of experience as biostatistician, oncology drug development experience would be an advantage

• Hands on experience, competent in design, descriptive and inferential statistics in clinical trials, biopharmaceutical applications.

• Experience in international pharmaceutical groups would be an advantage, good interpersonal and project management skills

• Fluent English and excellent communication skills, well-organized

• Be initiative and good team player as well, open-minded and resulted-oriented

职位4

The Senior Manager/Associate Director-Medical Analytics will be the statistical lead responsible for all aspects for product(s)/project(s) in regards to Medical Affairs activities.

We define future research questions, plan and execute statistical analysis, provide input into Medical Affairs and HEOR studies. Interpret, explain, and discuss results of sophisticated statistical analyses. Working in a diverse team with a range of interfaces, the role requires both strategic and operational skills combining innovative statistical thinking.

Overall

Statistical Expertise in Study Design and Analysis

Provides research study design, formulates novel methods to problem solving, and independently develop the statistical analysis plan to implement those solutions.

1. For Medical Affairs- Develop analysis using the clinical database for scientific meetings, publications, and internal decision-making (generally based on previously conducted randomized clinical trials).

2. For Health Economics and Outcomes Research including meta-analysis (including Bayesian network meta-analysis), patient reported outcomes (including development/validation), studies using external databases (e.g., claims, EMR, etc.), HTA/reimbursement/value dossiers, and real world studies.

3. For new studies (e.g., Phase IIIb/IV) including randomized studies, observational (non-randomized) studies, registries, non-interventional studies, cluster randomization, pragmatic clinical trials, etc.

Plan and Execute Statistical Analysis

Author the Statistical Analysis Plan (SAP) to define the appropriate statistical analyses to address research questions and the display shells for the outputs to be generated in collaboration with key partners.

Medical Analytics Departmental Initiatives

Develop standards within Medical Analytics including statistical position papers, standard analysis/display catalogues, and SAS macro libraries.

This role might be for you if:

1. ·You are proficient in SAS and enjoy solving sophisticated problems.

2. ·You can operate effectively working across multiple Medical Affairs teams

3. ·You like to ask challenging questions that lead to innovations

4. ·You are comfortable presenting to Senior Leadership

Education/Training

To be considered for this position you should have a minimum of an MS with at least 6 years of proven experience or PhD in statistics/biostatistics/ epidemiology with at least 2 years of demonstrated ability in generating solutions to problems presented by medical and commercial personnel within the biopharmaceutical industry. Knowledge of current statistical methods, at least 5 years using SAS to solve statistical problems, and experience with sample size calculation software (East, PASS, AddPlan, Nquery, etc.). Any experience with Medical Affairs, HEOR or Phase IV studies is helpful.

职位5 Responsibilities include:

Act as the lead programmer for assigned projects to coordinate and manage all statistical programming activities to ensure statistical programming deliverables on schedule and according to quality standards from study start-up through archival for clinical studies

Establish and manage the partnership with Biostatistics vendors and participate in vendor selection for statistical programming services for clinical studies

Create, review, approve, and/or execute statistical programming plans for the statistical analysis and reporting of clinical study data, which include development of SDTM/ADaM data specifications, creation of SDTM/ADaM datasets and TFLs, performing QC of datasets and TLFs, conducting dry-runs and final analysis, and supporting ad-hoc analysis requests, etc.

Plan and oversee the programming activities for outsourced clinical studies and QC of datasets (SDTM/ADaM) and TLFs following CDISC/Luye standards

Oversee the development and maintenance of appropriate documentations of all programming deliverables and ensure audit-ready conditions of these documentations

Provide input on CRF design, database design, data quality surveillance plan, statistical analysis plan and TLFs shell, etc.

Plan and oversee the development and execution of statistical analysis and reporting deliverables for regulatory submissions

Work effectively with internal/external functional teams to ensure high quality deliverables and maintain efficient communication with all parties including global team

Provide input on project timeline and budget

Lead the development/improvement of statistical programming standard processes, including CDISC compliant data standards, standard review and approval process for CRO deliverables, programing/QC tracking process, and data specification template, etc., to increase efficiency, qualify or cost savings

Participate in quality assurance activities and coordinate resolution of audit findings

Provide coaching and mentoring to junior staff, and manage the direct reports if needed

Ensure adherence to company SOPs, GCP, ICH guidelines, and all applicable local and international regulation

Qualifications:

A Master’s degree or equivalent in Mathematics, Statistics, Biostatistics, Engineering, Computer Science, or related fields

5+ years of working experience in pharmaceutical/clinical trial environment

Solid programing background and hands on experience on statistical programming in pharmaceutical/clinical trial environment

Good understanding of CDISC (SDTM/ADaM) data standards, statistical programming standards and related regulatory requirements

Broad knowledge and prior experience in NDA/BLA submissions in eCTD format and responding to regulatory agencies (e.g. FDA/EMA/PMDA) requests are preferable

Ability to work independently to identify and solve complex problems with minimal supervision

Strong analytical, organizational, and project management skills

Strong written/oral communications and interpersonal skills

Experience working with vendors/CROs is preferred