Sanofi Group Head of Biometrics in Cheyenne, Wyoming
Job summary and key strategic intent
The Head, Biometrics leads the biometrics function (including biostatistics, data management and statistical programming) to support clinical trials at Amunix. In this capacity, the successful candidate will recruit, develop, and supervise appropriately qualified personnel to achieve functional goals and execute on statistical strategy, design and analyses for clinical trials in all phases. Responsible for establishing ideal FIH trial designs, and ensuring appropriate statistical parameters are in place for determining dose, safety and efficacy of pipeline molecules. Applies sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements. Develops and/or applies statistical theories, methods and software. Partners closely with clinical in program design and in 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 leaders in other functions. Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success. Will represent biostatistics function in interactions with Health Authorities, institutional review boards and ethics committees. Manages timelines, deliverables and budgets of contract research organizations.
Key duties and responsibilities
Develop and build a Biometrics group. Direct a group of data managers, SAS programmers in their technical work. Recruit and train new biostatisticians and programmers as necessary.
Keep current and evaluate new statistical procedures or novel uses of traditional methodology with respect to potential application to oncology clinical trials as well as existing and proposed regulatory guidelines pertaining to the content and format of the statistical aspects of the components required for submissions to regulatory agencies.
Draft, review and provide guidance for statistical sections of protocols, statistical analysis plans and for soundness of trial design.
Oversee clinical database build and ensure soundness of case report forms used in clinical databases
Perform analyses, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
Interact with regulatory agencies to ensure clinical studies meet regulatory requirements.
Work closely with Clinical Operations function and 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.
Identify and solve problems which arise in the course of data processing and biostatistical analysis.
Proactively identify the need for additional statistical, data and clinical software.
Keep department heads and key functions informed of progress and issues affecting meeting project goals.
Draft, review and finalize statistical aspects of interim and final study reports to ensure that the biostatistical findings have been appropriately incorporated.
As part of a clinical assessment team, collaborate in the preparation and review of clinical data assessments.
Prepare performance plans and appraisals for direct reports. Make recommendations for merit increases and promotions. Maintain personal development plans for each employee.
Lead, Support and Oversee execution of Clinical Development Activities
Review all key documentation such as IND/CTA, health authority communications and other documents (DUSR, INDAR, DRMP, RMP, etc), protocols and amendments
For a given study, coordinate with CMC leadership and Clinical Operations at all levels of development from drug supply, quality, timelines, budget
Review all data generated across the program to update strategy and risk assessment
Regular review of competitive intelligence to update risk, differentiation and valuation of program
Skills, competencies required
At least 10 years of experience as a biostatistician supporting clinical trials, preferably in the therapeutic area of oncology and in the biotech/pharmaceutical industry.
Management and statistical analysis of data obtained from Phase I - III clinical studies in support of INDs, CTAs, BLAs.
Comprehensive and detailed knowledge of: statistical experimental designs, analyses and clinical trial requirements, particularly pertaining to oncology trials
Statistical software such as: SAS, EAST, nQuery, Cytel Studio
Excellent knowledge of FDA/EU statistical guidelines.
Strong expertise in clinical development and methodology of clinical studies
Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
Demonstrated supervisory and training abilities
Capability to challenge decision and status quo with a risk-management approach
Ability to negotiate to ensure operational resources are available for continued clinical conduct
Excellent supervisory skills, demonstrated ability to assist and train others
International/ intercultural working skills
Education and background
PhD in statistics or biostatistics
10 + years in pharmaceutical industry or CRO, previous experience in clinical development in cancer therapies
Experience with Health Authority interactions
Complexity and problem solving
The position works in a fast paced, intense environment, often with multiple clinical development programs in a variety of global regions with varying regulatory, medical and market access conditions.
The suitable candidate will need to influence and coordinate activities across varying geographies.
Independent creative thinking related to overcoming hurdles and problems.
An ability to anticipate problems and changes is essential.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
The salary range for this position is $222,245.63 - 296,327.50 to $370,409.38. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the link, www.benefits.sanofiusallwell.com
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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