-
Director Biostatistics
6 days ago
Pfizer Collegeville, United StatesWHY PATIENTS NEED YOU · You must possess the ability to plan, direct and coordinate a variety of specialized and complex global development projects, must have knowledge of clinical design of experiments, clinical data management and programming tools, and ability to interpret re ...
-
Associate Director, Biostatistics
6 days ago
Pfizer Collegeville, United StatesWHY PATIENTS NEED YOU · Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure o ...
-
Executive Director, Biostatistics
1 week ago
Madrigal Pharmaceuticals Inc Conshohocken, United StatesThe Executive Director of Biostatistics is an individual contributor that will lead multiple biostatistical activities for Madrigal Pharmaceuticals, covering all phases of clinical development. This role will collaborate with other biostatisticians and programmers either in the c ...
-
Director Biostatistics
2 days ago
Pfizer Collegeville, United StatesPfizer · Director Biostatistics · Collegeville , · Pennsylvania · Apply Now · Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and techno ...
-
Executive Director, Biostatistics
1 week ago
Madrigal Pharmaceuticals Inc Conshohocken, United StatesThe Executive Director of Biostatistics is an individual contributor that will lead multiple biostatistical activities for Madrigal Pharmaceuticals, covering all phases of clinical development. This role will collaborate with other biostatisticians and programmers either in the c ...
-
Executive Director, Biostatistics
1 week ago
Madrigal Pharmaceuticals Inc Conshohocken, United StatesThe Executive Director of Biostatistics is an individual contributor that will lead multiple biostatistical activities for Madrigal Pharmaceuticals, covering all phases of clinical development. This role will collaborate with other biostatisticians and programmers either in the c ...
-
Executive Director, Biostatistics
1 week ago
Madrigal Pharmaceuticals Corporation Conshohocken, United StatesJob Description · Job DescriptionThe Executive Director of Biostatistics is an individual contributor that will lead multiple biostatistical activities for Madrigal Pharmaceuticals, covering all phases of clinical development. This role will collaborate with other biostatistician ...
-
Executive Director, Biostatistics
3 days ago
Madrigalpharma Conshohocken, United States Full timeThe Executive Director of Biostatistics is an individual contributor that will lead multiple biostatistical activities for Madrigal Pharmaceuticals, covering all phases of clinical development. This role will collaborate with other biostatisticians and programmers either in the c ...
-
Associate Director, Biostatistics
1 day ago
Pfizer Collegeville, PA, United StatesWHY PATIENTS NEED YOUPfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our ...
-
Associate Director, Biostatistics
2 days ago
Pfizer Collegeville, United StatesWHY PATIENTS NEED YOUPfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our ...
-
Director Biostatistics, Oncology
3 days ago
Penfield Search Partners Wilmington, United States PermanentContact: Mark Maurer – · Job Description: The Statistical Science Director provides technical leadership as an expert for a number of statistical processes and systems that ensures effective collaboration between a technical services group and company regional sites and custome ...
-
Clinical Development Director
3 weeks ago
GSK Collegeville, United States**Site Name**: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence · **Posted Date**: Apr · - Are you energized by the opportunity to partner with key leaders in global medical science to accelerate business performance across and drive global operational suppo ...
-
Senior Statistical Programmer
2 weeks ago
CSL Behring King of Prussia, United States Full timeCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. · With operations in 35 ...
-
Senior Statistical Programmer
4 days ago
CSL Behring King of Prussia, United StatesJob Description · CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. · Wit ...
-
Senior Statistical Programmer
22 hours ago
CSL Behring San Francisco, United States PermanentCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. · With operations in 35 ...
-
Senior Statistical Programmer
1 week ago
CSL Behring King of Prussia, United StatesCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ n ...
-
Senior Statistical Programmer
1 week ago
BioSpace, Inc. King of Prussia, United StatesJob Details · CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. · With ...
-
Senior Statistical Programmer
1 week ago
CSL Behring King of Prussia, United StatesCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. · With operations in 35 ...
-
NexEos Bio Malvern, United StatesDirector, Clinical Trials Management/Clinical Operations · FLSA: Exempt · Reports to: President, R&D · Location: Hybrid · Date Prepared: 21,05,2024 · The successful candidate will have demonstrated successful experience managing clinical operations in small or mid-sized CROs and/ ...
-
Medical Director, Clinical Development
1 week ago
Harmony Biosciences LLC Plymouth Meeting, United StatesHarmony Biosciences is recruiting for a Medical Director, Clinical Development & Strategy in our Plymouth Meeting, PA location. · In this role you will be responsible for leading and driving input into clinical development strategy for key programs and studies for Harmony Biosci ...
Sr Director, Biostatistics - King of Prussia, United States - Exelixis
Description
SUMMARY/JOB PURPOSE:
Provides leadership to the biostatistics function and direct management of biostatistics staff in developing statistical strategy, design, and analyses for clinical trials for multiple compounds with a focus on early phase (1/2) trials.
Applies sound statistical methodology to meet key project objectives related to early development including clinical biomarker and translational medicine objectives.
Develops and/or applies statistical theories, methods, and software.Partners in early clinical development program study design, biomarker strategy and translational medicine strategy establishing standards for clinical conduct, and the collection, management and/or reporting of data.
Recruits, develops, and supervises project statisticians.Takes a leadership role in developing and implementing biostatistics department policies, standards, practices, and work-instructions in coordination with senior leaders in biometrics and other functions.
Conceptualizes and implements initiatives for process improvement and or standardization for biostatistics activities and deliverables. Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success. Manages timelines, deliverables, and budgets of contract research organizations.ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsible for all statistical oversight of early development projects.
Provide strategic input on Exelixis early development clinical development programs
Provides critical input on translational medicine and clinical biomarker strategy
Provide vision and direction for the development and implementation of department standards and practices and oversite of process improvement initiatives
Provide technical oversight of the statistical design, conduct, and analysis of early phase clinical trials.
Review protocols for soundness of trial design.
Review statistical analysis plans and case report forms.
Lead and directly manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, costs, methods, and resourcing.
Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements and ensure ongoing agreement on project development.
Contribute to the development of Requests-for-Proposals for evaluation of Contract Research Organizations and other vendors providing services for biostatistics, and programming activities.
Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables, and budgets.Interpret, execute, and recommend modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.
Build strong relationships both within and outside biostatistics
SUPERVISORY RESPONSIBILITIES:
Direct management and supervision of biostatisticians.
Indirectly supervise employees in other functions through a dotted line structure or via other subordinate supervisors.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of 13 years of related experience; or,
PhD in Statistics/Biostatistics or related discipline and a minimum of 12 years of related experience; or,
Equivalent combination of education and relevant experience in oncology.
Experience/The Ideal for Successful Entry into Job:
Managed clinical trials in the therapeutic area of oncology for at least 5+ years and other therapeutic areas for 10+ years.
Experience working with and analyzing clinical biomarker and large genetics and omics datasetsExperience managing multiple statisticians.
Has led phase 1 and phase 2 oncology studies.
Knowledgeable regarding FDA/EMA/ICH guidelines for drug development, new methodology in statistics and statistical/clinical data analyses.
Knowledge of CDISC standards.
Ability to work simultaneously on multiple projects and multiple compounds, and to deliver high-quality work according to tight timelines.
Experience interacting directly with FDA and/or EU Authorities preferred.
Knowledge/Skills:
Strong people management and interpersonal skills
Strong communication skills
Strong conflict management skills
Comprehensive and detailed knowledge of statistical experimental designs, analyses, and clinical trial requirements, particularly pertaining to early development oncology trials.
Excellent knowledge of FDA/EU/ICH statistical guidelines.Has functional understanding of other disciplines such as data management, clinical operations, clinical science, regulatory affairs, and drug safety.
Project management and contract negotiation with outside vendors.
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve these goals in creative and effective ways.
Develops technical and/or business solutions to complex problems.Applies strong analytical and business communication skills.
JOB COMPLEXITY:
Works on significant and unique issues where analysis scenarios require an evaluation of intangibles.
Works on complex issues where analysis scenarios require an in-depth knowledge of the company.
Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results.
Participates in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people.
Ensures budgets and schedules meet corporate requirements.
Creates formal networks involving coordination among groups.
#LI-CW
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us
Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets.
The base pay range for this positionis $233,000 - $330,500 annually.
The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.
It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
#J-18808-Ljbffr