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Director/Associate Director, Biostatistics

Remote:

Full Remote

Contract:

Full time

Experience:

Senior (5-10 years)

Work from:

Massachusetts (USA), United States

Offer summary

Qualifications:

MS required; Ph.D. preferred in Biostatistics or Statistics., 6+ years experience in drug development., Experience with neuromuscular diseases preferred., Familiarity with regulatory submissions strongly preferred., Hands-on experience with SAS and R programming..

Key responsabilities:

Lead development of statistical study protocols and analysis plans.
Optimize trial designs for registrations through strategic input.
Collaborate with cross-functional teams for timely deliverables.
Oversee CRO activities and manage contractors effectively.
Communicate complex statistical concepts to diverse audiences.

PepGen Scaleup https://pepgen.com/

51 - 200 Employees

See more PepGen offers

Job description

Director / Associate Director, Biostatistics

As Director / Associate Director of Biostatistics, you will work in collaboration with the Head of Biostatistics to provide strong statistical support to advance PepGen’s clinical development programs. You will serve as the statistical subject-matter expert on our cross-functional teams with significant contribution to protocol development, study design, statistical analysis, regulatory submissions, publications and presentations, as well as managing CRO and external vendors.

Responsibilities:

Lead the development of statistical sections of clinical study protocols, statistical analysis plans (SAP) and conduct the analysis and reporting of clinical trial data, including review of Tables, Listings, Figures (TLFs), SDTM and ADaM specifications, clinical study reports (CSR), and regulatory submission documents
Provide strategic input to optimize trial designs for pivotal registrational studies; maintain advanced competencies in statistical methodology and innovative trial designs, particularly in therapeutic areas such as neuromuscular diseases or other rare diseases, familiarity with ICH, FDA, and EMA guidelines
Representing the biostatistics function, proactively collaborate with internal and external cross functional teams to ensure timely statistics deliverables; oversee CRO statistical activities and effectively manage contractors and vendors
Contribute to the development of Biostatistics SOPs and standards
Effectively communicate complex statistical concepts in written and verbal context to a broad audience

Requirements

Minimum of MS required (Ph.D. strongly preferred) in Biostatistics, Statistics, or other related fields with 6+ years of overall experience in drug development in the pharmaceutical industry
Experience in therapeutic areas such as neuromuscular diseases or other rare diseases preferred
Knowledgeable about a broad range of statistical topics in different phases of drug development, including efficacy, safety, and PRO endpoints and innovative study designs
Regulatory (s)NDA/BLA/MAA submission experience strongly preferred
Must have hands-on experience with SAS and R programming in clinical trials
Experience with managing CROs and contractors
Ability to work onsite in Boston Office Tuesday – Thursday

Note: This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week.

About PepGen:
PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases. For more information, visit www.pepgen.com or follow PepGen on Twitter and LinkedIn.

EEO Statement
PepGen is an Equal Opportunity Employer 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.

Recruitment & Staffing Agencies: PepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all of our recruiting needs. Thank you.
The Scientist, Drug Substance will support the manufacturing and development of PepGen’s Enhanced Delivery Oligonucleotides (EDOs) pipeline. This role involves working closely with PepGen’s CMC team and external CMO/CRO partners to contribute to drug substance process development. The ideal candidate will bring innovative ideas and a collaborative spirit to a fast-paced, growth-oriented biotech company.