The Senior Director of Biostatistics will report to the Vice
President of Biometrics and Data Management. The Senior Director of
Biostatistics will be the statistical expert in at least one of
Dicerna’s drug development programs. The successful candidate will
provide leadership and guidance on designing studies, selecting
appropriate and innovative statistical methods, analyses,
interpretation, and reporting of study results. The person will
lead and oversee biometric focused regulatory interactions and
submissions to the FDA and other regulatory agencies; Additional
mentoring and delegation of tasks will be required as appropriate.
The person will participate in the development and implementation
departmental standards, applications, processes, and training.
Contribute in study level tasks from statistics perspective,
including but not limiting to: study design and sample size
determination; author/review statistics section in the protocol,
SAP and DMC charter; create/review study randomization files;
develop TFL shell and specification; review CRFs and other study
documentations; active participation in study related meetings.
Lead in product level tasks including regulatory interactions
and filing, and ensure statistical integrity; contribute
strategically to the supporting projects from the statistics
Work collaboratively with cross-functional teams to meet product
deliverables and timelines for statistical data analysis and
Oversee statistical work by CRO and ensure quality deliverables
with respect to key performance indicators, metrics, and program
level deliverables and timelines.
Translate statistical thinking into a strategic input to advance
the clinical program.
Independently conduct analyses suggested by the data; propose
new/novel statistical methodological approaches to improve the
efficiency and sensitivity of study results.
Ensure statistical integrity of deliverables; provide
statistically sound scientific methodology input to meet project
objectives and regulatory statistical and data requirements.
Lead in developing department standards and research in advanced
Ability to potentially manage lower level statisticians and
Author/review regulatory documents or scientific
Contribute to project budget/resource planning, re-forecasting,
and program milestones.
PhD in Statistics, Biostatistics or Mathematics with a minimum
12 years’ experience (or MS with minimum 15 years’ experience) in
the pharmaceutical/biotech/device industry.
Minimum of at least 3 years’ supervisory and mentoring
Excellent writing, communication and interpersonal skills, with
the ability to translate statistical concepts to program
Strong ability to prioritize tasks to statistical and
Prior experience at outsourcing and managing biostatistical
services provided by CRO's and contractors.
Experienced as product lead statistician and contribute to
strategy discussion in cross-functional settings; Experienced in
managing multiple products and studies and being able to
Prior experience in study level work including authoring SAP and
Develop SAS programs as necessary to perform planned or ad hoc
analyses and prepare data displays.
Lead development of department SOPs.
Familiar with ICH guideline, FDA/EMA/other regulatory authority
Solid understanding of mathematical and statistical principles;
Experience in statistical methods (longitudinal data analyses,
Bayesian method, adaptive design) is preferred.
Detailed-oriented with organization, problem-solving and
prioritization skills; demonstrated the ability to prioritize and
complete multiple tasks according to company timeline.
Familiar with SAS and/or R; knowledge and experience in CDISC
requirements including SDTM, ADaM, and controlled
U.S. Equal Opportunity Employment Information (Completion is
voluntary) Individuals seeking employment at Dicerna are considered
without regards to race, color, religion, national origin, age,
sex, marital status, ancestry, physical or mental disability,
veteran status, gender identity, or sexual orientation. You are
being given the opportunity to provide the following information in
order to help us comply with federal and state Equal Employment
Opportunity/Affirmative Action record keeping, reporting, and other
Completion of the form is entirely voluntary . Whatever your
decision, it will not be considered in the hiring process or
thereafter. Any information that you do provide will be recorded
and maintained in a confidential file.
Gender Please select Are you Hispanic/Latino? Please select Race
& Ethnicity Definitions If you believe you belong to any of the
categories of protected veterans listed below, please indicate by
making the appropriate selection. As a government contractor
subject to Vietnam Era Veterans Readjustment Assistance Act
(VEVRAA), we request this information in order to measure the
effectiveness of the outreach and positive recruitment efforts we
undertake pursuant to VEVRAA. Classification of protected
categories is as follows:
A "disabled veteran" is one of the following: a veteran of the
U.S. military, ground, naval or air service who is entitled to
compensation (or who but for the receipt of military retired pay
would be entitled to compensation) under laws administered by the
Secretary of Veterans Affairs; or a person who was discharged or
released from active duty because of a service-connected
A "recently separated veteran" means any veteran during the
three-year period beginning on the date of such veteran's discharge
or release from active duty in the U.S. military, ground, naval, or
An "active duty wartime or campaign badge veteran" means a
veteran who served on active duty in the U.S. military, ground,
naval or air service during a war, or in a campaign or expedition
for which a campaign badge has been authorized under the laws
administered by the Department of Defense.
An "Armed forces service medal veteran" means a veteran who,
while serving on active duty in the U.S. military, ground, naval or
air service, participated in a United States military operation for
which an Armed Forces service medal was awarded pursuant to
Executive Order 12985.
Veteran Status Please select Form CC-305
OMB Control Number 1250-0005
Voluntary Self-Identification of Disability Why are you being
asked to complete this form? We are a federal contractor or
subcontractor required by law to provide equal employment
opportunity to qualified people with disabilities. We are also
required to measure our progress toward having at least 7% of our
workforce be individuals with disabilities. To do this, we must ask
applicants and employees if they have a disability or have ever had
a disability. Because a person may become disabled at any time, we
ask all of our employees to update their information at least every
Identifying yourself as an individual with a disability is
voluntary, and we hope that you will choose to do so. Your answer
will be maintained confidentially and not be seen by selecting
officials or anyone else involved in making personnel decisions.
Completing the form will not negatively impact you in any way,
regardless of whether you have self-identified in the past. For
more information about this form or the equal employment
obligations of federal contractors under Section 503 of the
Rehabilitation Act, visit the U.S. Department of Labor’s Office of
Federal Contract Compliance Programs (OFCCP) website at
How do you know if you have a disability? You are considered to
have a disability if you have a physical or mental impairment or
medical condition that substantially limits a major life activity,
or if you have a history or record of such an impairment or medical
Disabilities include, but are not limited to:
Autoimmune disorder, for example, lupus, fibromyalgia,
rheumatoid arthritis, or HIV/AIDS
Blind or low vision
Cardiovascular or heart disease
Deaf or hard of hearing
Depression or anxiety
Gastrointestinal disorders, for example, Crohn's Disease, or
irritable bowel syndrome
Missing limbs or partially missing limbs
Nervous system condition for example, migraine headaches,
Parkinson’s disease, or Multiple sclerosis (MS)
Psychiatric condition, for example, bipolar disorder,
schizophrenia, PTSD, or major depression
Disability Status Please select 1 Section 503 of the
Rehabilitation Act of 1973, as amended. For more information about
this form or the equal employment obligations of Federal
contractors, visit the U.S. Department of Labor's Office of Federal
Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp
PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction
Act of 1995 no persons are required to respond to a collection of
information unless such collection displays a valid OMB control
number. This survey should take about 5 minutes to complete.
Your full LinkedIn profile
will be shared. Learn More