Biostatistics Director
$187.5k - $266kExelixis Inc
Provides leadership within biostatistics function to develop and execute statistical strategy, design and analyses for clinical trials in all phases. Applies sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements. Develops and/or applies statistical theories, methods and software. Partners in clinical development program, study design, establishing standards for clinical conduct, and the collection, management and/or reporting of data. Develops and implements biostatistics department policies, standards, practices and work-instructions in coordination with department leader and leaders in other functions. Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success. Represents biostatistics function in interactions with institutional review boards, ethics committees, and health agencies. Manages timelines, deliverables and budgets of contract research organizations.
- Work with department head to develop and implement department standards and practices.
- Direct the statistical design, conduct, and analysis of clinical trials in all phases.
- Review protocols and case report forms for soundness of trial design.
- Review and or author statistical analysis plans for all phases of a trial.
- Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
- Direct the development, validation and summary of integrated safety and efficacy summaries.
- Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements.
- Attend meetings with FDA or EU Authority to ensure ongoing agreement on project development.
- Contribute to the development of Requests-for-Proposals.
- Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.
- Responsible for all statistical oversight within a therapeutic area.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:- BS/BA degree in Statistics/Biostatistics or related discipline and a minimum of thirteen years of related experience; or,
- MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of eleven years of related experience; or,
- PhD in Statistics/Biostatistics or related discipline and a minimum of eight years of related experience, or;
- Equivalent combination of education and experience.
- May require certification in assigned area.
- Managed and or supported clinical trials, preferably in the therapeutic area of oncology and in the biotech/pharmaceutical industry.
- Preferably led a phase III clinical trial.
- In-depth knowledge of CDISC standards.
- Management and statistical analysis of data obtained from Phase I – IV clinical studies in support of US NDAs.
- Direct experience with FDA/EU Authority preferred.
- Typically requires a minimum of 15 years of related experience and/or combination of experience and education/training.
- Comprehensive and detailed knowledge of: statistical experimental designs, analyses and clinical trial requirements, particularly pertaining to oncology trials.
- Developed/reviewed SDTM/ADaM specifications.
- Excellent knowledge of FDA/EU statistical guidelines.
- Management and statistical analysis of data obtained from Phase I – IV studies in support of NDAs.
- Must have experience in state-of-the-art data organization and statistical analyses using statistical software such as: SAS, EAST, nQuery, Cytel Studio.
- Guides the successful completion of major programs, projects and/or functions by identifying and implementing appropriate techniques and evaluation criteria.
- Has understanding of other disciplines such as data management, clinical operation, 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.
- Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.
- 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. Regularly interacts with executives and/or major customers.
#LI-CW1
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 $187,500 - $266,000 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. SUMMARY/JOB PURPOSE: Provides leadership within biostatistics function to develop and execute statistical strategy, design and analyses for clinical trials in all phases. Applies sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements. Develops and/or applies statistical theories, methods and software. Partners in clinical development program, study design, establishing standards for clinical conduct, and the collection, management and/or reporting of data. Develops and implements biostatistics department policies, standards, practices and work-instructions in coordination with department leader and leaders in other functions. Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success. Represents biostatistics function in interactions with institutional review boards, ethics committees, and health agencies. Manages timelines, deliverables and budgets of contract research organizations. Essential Duties And Responsibilities:- Work with department head to develop and implement department standards and practices.
- Direct the statistical design, conduct, and analysis of clinical trials in all phases.
- Review protocols and case report forms for soundness of trial design.
- Review and or author statistical analysis plans for all phases of a trial.
- Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
- Direct the development, validation and summary of integrated safety and efficacy summaries.
- Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements.
- Attend meetings with FDA or EU Authority to ensure ongoing agreement on project development.
- Contribute to the development of Requests-for-Proposals.
- Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.
- Responsible for all statistical oversight within a therapeutic area.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:- BS/BA degree in Statistics/Biostatistics or related discipline and a minimum of thirteen years of related experience; or,
- MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of eleven years of related experience; or,
- PhD in Statistics/Biostatistics or related discipline and a minimum of eight years of related experience, or;
- Equivalent combination of education and experience.
- May require certification in assigned area.
- Managed and or supported clinical trials, preferably in the therapeutic area of oncology and in the biotech/pharmaceutical industry.
- Preferably led a phase III clinical trial.
- In-depth knowledge of CDISC standards.
- Management and statistical analysis of data obtained from Phase I – IV clinical studies in support of US NDAs.
- Direct experience with FDA/EU Authority preferred.
- Typically requires a minimum of 15 years of related experience and/or combination of experience and education/training.
- Comprehensive and detailed knowledge of: statistical experimental designs, analyses and clinical trial requirements, particularly pertaining to oncology trials.
- Developed/reviewed SDTM/ADaM specifications.
- Excellent knowledge of FDA/EU statistical guidelines.
- Management and statistical analysis of data obtained from Phase I – IV studies in support of NDAs.
- Must have experience in state-of-the-art data organization and statistical analyses using statistical software such as: SAS, EAST, nQuery, Cytel Studio.
- Guides the successful completion of major programs, projects and/or functions by identifying and implementing appropriate techniques and evaluation criteria.
- Has understanding of other disciplines such as data management, clinical operation, 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.
- Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.
- 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. Regularly interacts with executives and/or major customers.
#LI-CW1
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 $187,500 - $266,000 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. About Us Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial. As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission. Cancer is our cause. Make it yours, too. #J-18808-Ljbffr Exelixis Inc$166.5k - $236.5k
...statistical applications and clinical data management procedures in the conduct of clinical trials.* Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings. **Knowledge/Skills:*** Knowledge of appropriate regulations,...SuggestedInterim roleLocal areaFlexible hours- ...Job Title: Associate Director Clinical Operations Location: San Francisco (Hybrid 1-3 days a week Onsite) Reports To: Executive... ...cross functionally with Clinical Development, Regulatory, Biostatistics, Data Management, and Medical Affairs Trial Execution and...Suggested3 days per week1 day per week
- ...Overview We are seeking an Associate Director of Quantitative Modeling to lead and execute advanced modeling and simulation strategies... ...role partnering closely with Clinical Pharmacology, Biostatistics, Clinical Development, and Regulatory teams to optimize development...Suggested
$185k
Founding HR / People Operations | Series A AI Startup | San Francisco (In-Person) Macmillan Davies is recruiting on behalf of a well-funded Series A AI company. They're hiring their first dedicated HR professional to own and scale core HR operations as they grow from...Suggested$185k - $240k
...San Francisco, CA or Los Angeles, CA Summary As Associate Director, HR Business Partner, you’ll serve as a trusted advisor and strategic force-partnering directly with leadership teams to shape the talent, culture, and organizational health of your client groups....SuggestedWork experience placementWork at officeLocal area- ...Elevate your career at the forefront of groundbreaking oncology treatments! Our client is seeking a dynamic and strategic Associate Director of Marketing (Promotions) to lead their promotional efforts in metastatic colorectal cancer (mCRC). This pivotal role offers the...
- ...directly with Quince & Co and is not a recruiter but a partner in their HR function. Position Summary: The Human Resources Director is responsible for overseeing all HR functions for the company, ensuring alignment with organizational goals. This includes managing...Work at officeLocal areaVisa sponsorship
$90k - $115k
Alza People Collective is representing a condfidential search for the next HR Manager. We are hiring a Human Resources Manager for a San Francisco based Events and Rental Company. (Located just South of San Francisco) We want to hear from you if you are creative...Local area$110k - $140k
...importantly, be a mensch in every sense of the word. SUMMARY: WISE SONS DELI is seeking an experienced, thoughtful, and strategic Director of People to lead the overall people strategy across our restaurants and support teams. This role partners closely with executive...Hourly payFull timeLocal areaShift work$130k
Job Title: Senior Human Resources Manager - Americas Location: San-Francisco Salary: $130,000 SUMMARY The Senior Human Resources Manager will oversee core HR functions in the region including compliance, payroll, employee relations, policy development, performance...Work at officeLocal area- ...Associate Director, Translational Medicine & Clinical Science - San Francisco Bay Area ABOUT THE ROLE The Associate Director of Translational Medicine will support clinical-stage programs as an individual contributor, working closely with clinical development, pharmacology...Full time2 days per week3 days per week
$180k - $247k
Senior HR Business Partner (Los Angeles or San Francisco – Hybrid) LHH Recruitment Solutions is partnering with a leading global professional services organization and assisting them search for a Senior HR Business Partner to support key business units and regions. ...Local area$82.35k - $101.71k
HR Business Partner Job Category: Human Resources Location: Alameda, CA - Corporate Office Alameda, CA 94501, USA Position Type: Full-Time Shifts Available: Full-Time | AM | Shifts: 8:00 AM – 5:00 PM | Days: Monday - Friday Expected starting wage range is...Hourly payFull timePart timeWork at officeLocal areaMonday to FridayShift workNight shiftWeekend work- Role: Interim/Fractional Benefits Lead (virtual/hybrid) with a San Francisco-based professional services firm Responsibilities: Our client seeks an experienced hands-on benefits leader who can operate independently to provide white-glove service for 200-250 employees...Hourly payInterim roleWork at officeFlexible hours
$136k - $172k
Senior HR Business Partner Alameda, CA About Us We are Sila, a next-generation battery materials company. Our mission is to power the world's transition to clean energy. To create this future, our team is building a better lithium-ion battery from the inside out...Work at office- ...Associate Clinical Science Director In collaboration with clinical and project teams of the company, the Associate Clinical Science Director designs, plans and develops clinical evaluation research studies in oncology with focus on solid tumors. This position may assist...
- ...growing team. If you are interested in building a new frontier in genetic medicine, please apply via . Job Description: Associate Director or Director, Nonclinical Development Position Overview: We are seeking an experienced and highly motivated Director of...
- A leading biopharmaceutical company in Alameda is seeking an Associate Digital Marketing Director for the Web Email team. This role will drive digital marketing strategies for product promotions and use data-driven insights to optimize campaigns. The ideal candidate will...
$75k - $85k
Are you a Human Resources Professional looking to get more out of their career? As an HR Account Manager with Group Management Services you'll have endless opportunities to expand your professional network and business acumen! As with all positions here at GMS, we ...Work at officeLocal areaFlexible hours$195k - $250k
About the Role The Head of Technology Development is a senior technical leader responsible for defining and executing the end‑to‑end technology strategy for Vivani’s device and drug–device combination product portfolio. This role drives innovation, leads cross-functional...Contract workHome officeFlexible hours- Company Description We are building the vertically integrated, distributed utility for hyperscalers. While legacy turbine manufacturers are sold out for the next half-decade, AI data centers are bleeding millions per day on idle compute. We wedge into this market with...Full timeRelocation
- ...We are recruiting on behalf of a global clinical stage biotech who are looking to hire an Associate Director Regulatory Affairs to join their team on a permanent basis. Working onsite in San Francisco 3 days per week, the ideal candidate will bring small molecule experience...Permanent employment3 days per week
- ...Associate Executive Director of Operations About the Company Mission-driven senior living organization Industry Hospital & Health Care Type Privately Held About the Role The Company is seeking an Associate Director of Operations for its mission-driven...
$156k
...Overview MUST BE A LICENSED Speech, Physical, or Occupational Therapist with Director of Rehab backgrounds in SNF At Powerback, we're on a mission to improve lives. As the leader in physical, occupational, speech, and respiratory therapies, we help older adults...Full timePart timeH1bWork from homeVisa sponsorshipRelocation package$90k - $110k
...Scion Staffing has been engaged to conduct a search for Associate Director of Operations for an RCFE community located in Oakland, CA. POSITION OVERVIEW: This RCFE community is a mission-driven senior living environment providing residential care and...Full timeTemporary workInterim roleImmediate start$172k - $344k
...and partners worldwide, with the reliability and scalability of cloud-native, enterprise-grade platforms. We are looking for a Director, Security to help accelerate growth across the U.S., Spain, and India. In this role, you will build and lead a world-class, globally...WorldwideShift work- ...Solutions Consulting - Applied AI | Director Searce AI leader accountable for Applied AI strategic hiring & revenue growth; Responsible for client engagement & thought leadership to modernize business & work ops with process consulting & AI solutions advisory....Immediate start
- ...shaping the future with brilliant minds. Ready to join our epic growth journey? What we are looking for: We are seeking a Director - Analytics to join our team. You bring a deep understanding of the pharmaceutical industry, along with detailed expertise in...
$75k - $95k
...Townhomes to provide housing discounts for MCC employees. Whom are we looking for? We are seeking a dedicated Childcare Center Director to lead our vibrant team. The Childcare Center Director will oversee the overall daily operations and ensure compliance with state...Summer holidayImmediate start$172.31k - $190.46k
...somewhere, waiting for someone to give me a chance to live..." - Client from Telecare What You Will Do to Change Lives The Director of Pricing will lead Telecare's corporate pricing strategy team to drive the development and management of pricing strategies...Full timePart timeLocal areaRemote workRelocation packageMonday to FridayShift workDay shift
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Biostatistics Director. Be the first to apply!
- director of culinary Alameda, CA
- director of community outreach Alameda, CA
- pathology director Alameda, CA
- director of aviation Alameda, CA
- director continuous improvement Alameda, CA
- director of benefits Alameda, CA
- director infection prevention Alameda, CA
- director of automation Alameda, CA
- director of fulfillment Alameda, CA
- cruise director Alameda, CA


