- Works collaboratively with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables
- Conducts statistical modeling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programs
- Contributes to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles
- Authors or reviews statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and authors or oversees the development of shells for tables, figures and listings
- Reviews case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses
- Designs and specifies randomization schedules; reviews and approves test randomization lists
- Provides statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents
- Reviews analysis dataset specifications
- Performs QC/QA of statistical deliverables including validation of key analysis results
- Performs ad hoc and exploratory statistical analyses as needed
- Contributes to clinical study reports, including authoring of statistical methods and interpretation of the study results
- Be responsible for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions
- Addresses statistical questions/comments from FDA and other regulatory agencies, and reviews and addresses comments by IRB/ECs
- Supports and contributes to the preparation of publications, including manuscripts, posters and oral presentations
- Contributes or leads standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement efforts
- Ph.D. in Statistics or related discipline
- At least five years of experience in the pharmaceutical or biotech industry for Associate Director; at least three years of experience in the pharmaceutical or biotech industry for Sr. Manager level
- Demonstrated ability and experience in the design, analysis and reporting of clinical trials
- Experience in NDAs, MAAs, or other regulatory submissions desirable, but not required
- In-depth knowledge of statistical methods for clinical trials
- Working knowledge of FDA, EMA and ICH regulations and guidelines
- Proficient in statistical programming in SAS and R
- Proficient in statistical design software such as EAST
- Ability to concurrently work on multiple studies
- Understanding of data standards, including SDTM and ADaM
- Ability to oversee statistical services provided by CRO's and/or contractors
- Ability to collaborate effectively with colleagues from other functions
- Excellent written and oral communication skills
-
Director, Biostatistics
3 weeks ago
Editas Medicine Cambridge, United StatesAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRI ...
-
Director, Biostatistics
1 week ago
Biogen Cambridge, United StatesJob Description · About This Role · This is a rare opportunity to join the Biostatistics function at Biogen, an established pioneer in biotechnology The Director of Biostatistics is responsible for leading complex or integrated study design and analysis across one or my programs ...
-
Director, Biostatistics
1 week ago
Biogen Cambridge, United StatesJob Description · About This Role · This is a rare opportunity to join the Biostatistics function at Biogen, an established pioneer in biotechnology The Director of Biostatistics is responsible for leading complex or integrated study design and analysis across one or my progra ...
-
Director, Biostatistics
4 days ago
Biogen Cambridge, United StatesAbout This Role This is a rare opportunity to join the Biostatistics function at Biogen, an established pioneer in biotechnology The Director of Biostatistics is responsible for leading complex or integrated study design and analysis across one or m Director, Development, Clinica ...
-
Director, Biostatistics
1 week ago
Biogen Cambridge, United StatesJob Description · Job DescriptionJob Description · About This Role · This is a rare opportunity to join the Biostatistics function at Biogen, an established pioneer in biotechnology The Director of Biostatistics is responsible for leading complex or integrated study design and a ...
-
Director, Biostatistics
3 weeks ago
Moderna Theraputics Cambridge, United StatesThe Role: · This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Director of Biostatistics will be involved in the design, execution, analysis, and reportin ...
-
Director, Biostatistics
2 weeks ago
Editas Medicine Cambridge, United StatesAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRI ...
-
Director, Biostatistics
1 week ago
Rhythm Pharmaceuticals Boston, United States Full time· Company Overview · Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide m ...
-
Director Biostatistics
1 week ago
Green Key Resources Boston, United StatesJob Description · Job DescriptionThe Director, Biostatistics provides leadership and guidance for large and/or complex late phase clinical development program(s). He/she is responsible for statistical activities including: designing innovative clinical trials, authoring statistic ...
-
Director Biostatistics
4 days ago
Intellia Therapeutics, Inc. Cambridge, United StatesWhy Join Intellia? · Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. · Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel str ...
-
Director, Biostatistics
1 week ago
Bristol-Myers Squibb Somerville, United StatesWorking with UsChallenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to ...
-
Director, Biostatistics
3 weeks ago
Deciphera Pharmaceuticals Watertown, United StatesCompany Description · Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise ...
-
Director Biostatistics
1 week ago
Birdseye Partners Waltham, United StatesAssociate Director / Director - Biostatistics · Our client is seeking a Associate Director/Director, Biostatistics to join their growing team. This person will be responsible to lead, develop, and implement statistical analyses to support the early development clinical trials, su ...
-
Director, Biostatistics
2 weeks ago
Biogen Cambridge, United StatesJob Description · About This Role · This is a rare opportunity to join the Biostatistics function at Biogen, an established pioneer in biotechnology The Director of Biostatistics is responsible for leading complex or integrated study design and analysis across one or my programs ...
-
Director, Biostatistics
1 week ago
Biogen Idec Cambridge, United StatesJob Description · About This Role · This is a rare opportunity to join the Biostatistics function at Biogen, an established pioneer in biotechnology The Director of Biostatistics is responsible for leading complex or integrated study design and analysis across one or my program ...
-
Associate Director, Biostatistics
2 weeks ago
Sarepta Therapeutics Cambridge, United StatesAssociate Director, Biostatistics page is loaded · Associate Director, Biostatistics · Apply · remote type · Remote · locations · Cambridge, MA · time type · Full time · posted on · Posted 4 Days Ago · job requisition id · R-02253 · The person in this position will b ...
-
Director, Biostatistics
2 weeks ago
Editas Medicine Cambridge, United StatesAt Editas, were driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRIS ...
-
Director Biostatistics
2 weeks ago
Intellia Therapeutics, Inc. Cambridge, United StatesWhy Join Intellia? · Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. · Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel stro ...
-
Director, Biostatistics
1 week ago
Bristol-Myers Squibb Somerville, MA, United StatesWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line t ...
-
Associate Director, Biostatistics
4 days ago
Pfizer Cambridge, United StatesWHY PATIENTS NEED YOU · 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 technologies into the therapies and vaccines that matter most. W ...
Associate Director, Biostatistics - Cambridge, United States - Sarepta Therapeutics
Description
The person in this position will be working with a cross functional team as the project biostatistician responsible for statistical activities at the compound level or study level for one or more Gene therapy programs. It is an excellent opportunity to work at the forefront of precision genetic medicine, making an impact to the development of transformative therapies that may change the lives of patients. The ideal candidate is a good communicator, high-energy, self-motivated, and forward thinking. Experience working in rare disease is desirable, but not required.
Primary Responsibilities Include:
This position is remote. However, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $156,000 - $195,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
