Statistical Scientist/Senior Statistical Scientist

South San Francisco
California, United States of America


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The Position

In this position, you will:

Contributing statistical and analytical direction, insights, recommendations and overall input into development and execution of 3- and 1-year medical strategies, plans, objectives and projects

Developing, implementing and overseeing timely, thorough, consistent, and quality execution of statistical analysis plans that support medical strategies, plans, projects and objectives and assure statistical integrity, adequacy and accuracy

Providing appropriate biostatistics inputs and direction for the assigned products into a variety of pre-launch, launch and postmarketing medical affairs activities

Identifying, recommending and undertaking exploratory analyses and statistical research that furthers the success of pre-launch, launch and post-marketing clinical trials and other studies and assessments

Participating in the ongoing development, refinement and enhancements of departmental methodologies and techniques for biostatistics research, analysis and reporting

Where assigned, acting as a standing member of the assigned Medical Team, participating in Biostatistics teams, as well as participating and/or making important contributions to other cross-functional teams and working groups

Developing and cultivating important working relationships with cross-functional teams and groups

As needed, representing U.S. Medical Affairs Biostatistics to global Roche partners and working collaboratively to coordinate and align statistical analysis plans and outcomes at the national and global levels

Staying informed and abreast of the external landscape as it relates to assigned molecules, products, and programs and the associated therapeutic area(s)

As assigned, completing other special projects

Ensuring assigned goals and objectives are met and that assigned projects and other work are completed on time, to high

standards and within budget

Strategy/Planning:

Maintain a high-level of scientific and clinical knowledge in the specific therapeutic area(s) of assignment as well as the highest levels of technical expertise in biostatistics research and analysis

Participate in the development of medical strategies, plans, projects and objectives in the assigned therapeutic area:

As appropriate, gathering and/or consolidating research, analytics and other information to support medical plan

development

As assigned, working as part of the cross-functional Medical Affairs Team to develop and contribute to all aspects of the 3- year and 1-year Medical Plans, including statistical and analytical requirements for clinical studies, projects and other

assessments, publication planning, interactions and communications with external partners, relevant medical meetings,

presentations, other events and forums

As appropriate, working with cross-functional teams and global Roche partners to align Genentech medical and statistical

analysis plans at the affiliate and global levels

Define, recommend and develop statistical analysis strategies, objectives and requirements for each clinical trial or other

study/investigation for assigned products, including health economics and outcomes research projects:

Assuming statistical responsibility for major segments of each project

Providing sound strategic, statistical and scientific input on project objectives, experimental design and data analysis to meet project needs and health authorities statistical and scientific requirements

Establishing data, analytical, statistical and reporting requirements for each study or other assessment. Includes working

with statistical programmers and data management to confirm, build and implement data and systems programs and

structuring

Serving as a Biostatistics contact on Study Management Teams (SMTs)

Reviewing all project designs and protocols

Authoring protocol statistical analysis sections and statistical analysis plans and manage study randomization code

generation

Skills/Abilities

When assigned, acting as a Biostatistics liaison for the team and primary statistical point-of-contact for medical monitor

inquiries from trial sites, CROs, etc.

Responding to questions regarding statistical protocol inquiries and other related matters

Operations:

Monitor and oversee pre-launch, launch and post-marketing clinical trials and other studies and assessments through to

completion, reporting and publication:

Planning and coordinating a myriad of Biostatistics team activities to ensure successful and timely completion of assigned projects

When assigned, participating in relevant internal advisory committees to stay fully abreast and apprised of study status and progress

Conducting ongoing in-depth reviews of data listings. Performing statistical analysis following established methodologies,

protocols and procedures to identify key patterns, themes, potential issues, opportunities and results

Reviewing Case Report Forms (CRFs) to ensure that protocol objectives are met and that project standards are maintained

Authoring statistical analysis results in the clinical study report or other relevant reporting

Managing report development and completion through internal and external reviews

Where applicable, participating in meetings or communications with external agencies, health authorities or other parties

Providing biostatics inputs in response to internal and external questions

As assigned, represent Biostatistics in publication planning, congress and other meeting/association planning and

management. Provide biostatistics content and input into publications and internal and external presentations. May also

present biostatistics information, plans and results at internal forums

Review materials from other internal partners, as appropriate, to ensure alignment and accuracy with biostatistics strategies, direction and results

Qualifications

PhD + 2 years’ experience or Masters Degree + 5 years’ experience in statistics/biostatistics (PhD is preferred)

Sound knowledge of ICH-GCP and other relevant standards and guidelines

Sound knowledge of theoretical and applied statistics

Must demonstrate sound knowledge of Phase IV/post-marketing drug development (knowledge of or experience with Phase I - III

drug development is preferred)

Relevant therapeutic area knowledge is a plus

2 or more years’ clinical trial experience

Relevant therapeutic experience is a plus

Proven experience in the principles and techniques of data analysis, interpretation and clinical relevance

Proven track record of meeting or exceeding objectives and goals

Outstanding attention-to-detail

Strong analytical and problem-solving capabilities and skills

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.


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