Head of Biometrics
Company: Sanofi Group
Posted on: September 13, 2023
**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
**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
+ 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
+ Interact with regulatory agencies to ensure clinical studies meet
+ 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
+ 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,
+ 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
+ Excellent communication skills (verbal and written) for
interactions across functional areas and for interactions with key
+ Demonstrated supervisory and training abilities
+ Capability to challenge decision and status quo with a
+ Ability to negotiate to ensure operational resources are
available for continued clinical conduct
+ Excellent supervisory skills, demonstrated ability to assist and
+ 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
+ The suitable candidate will need to influence and coordinate
activities across varying geographies.
+ Independent creative thinking related to overcoming hurdles and
+ 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,
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
Keywords: Sanofi Group, Honolulu , Head of Biometrics, Other , Honolulu, Hawaii
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